Novo Nordisk A/S: Semaglutide 2.4 mg (Wegovy®) cardiovascular outcomes data presented at American Heart Association Scientific Sessions and simultaneously published in New England Journal of Medicin
Semaglutide 2.4 mg delivered a statistically significant 20% risk reduction in major adverse cardiovascular events (MACE) with risk reductions demonstrated consistently across age, gender, ethnicity and starting body mass index (BMI).
Beneficial effects were seen consistently across measured cardiovascular endpoints with semaglutide 2.4 mg.
Risk reductions in MACE were evident soon after initiation, suggesting an effect of semaglutide 2.4 mg beyond weight loss alone.
Bagsværd, Denmark, 11 November 2023 - Novo Nordisk today announced the primary results of SELECT, its landmark phase 3 cardiovascular outcomes trial investigating the effects of once-weekly semaglutide 2.4 mg (Wegovy®) in adults with established cardiovascular disease (CVD) and overweight or obesity without diabetes at the American Heart Association (AHA) annual Scientific Sessions in Philadelphia. The data were simultaneously published in the New England Journal of Medicine (NEJM). 1
Previously reported top-line results showed semaglutide 2.4 mg delivered a statistically significant 20% risk reduction in MACE over a period of up to five years versus placebo (HR: 0.80; 95% confidence interval: 0.72; 0.90, p<0.001). Today's findings showed that risk reductions in MACE were achieved regardless of age, gender, ethnicity and starting body mass index (BMI).1 The results also demonstrated that the beneficial effects in MACE risk reduction were evident soon after treatment initiation, suggesting an effect that is more rapid than what would be expected if the cardiovascular effects were entirely mediated with the effects of semaglutide 2.4 mg on body weight reduction.1 This suggests that weight loss alone may not fully explain the benefits of semaglutide 2.4 mg in reducing the risk of MACE.1
Every year almost 18 million people die from CVD which is the leading cause of disability and death worldwide.2,3,4 While cardiovascular mortality has decreased over the past two decades, obesity-related cardiovascular deaths have increased significantly.5 Obesity leads to cardiovascular morbidity and mortality and is associated with risk factors such as high blood pressure and inflammation.3,6
"For the first time, we have evidence that semaglutide 2.4 mg improves cardiovascular outcomes in at-risk patients with BMI of 27 and above with established CVD, without diabetes," said Dr Michael Lincoff, lead study author, vice chair for research in the Cleveland Clinic Department of Cardiovascular Medicine, and a paid consultant for Novo Nordisk. "The three-point MACE risk reduction observed in SELECT suggests the potential for a new option in obesity treatment, addressing some of the leading causes of preventable death worldwide."
Analyses of the three components in MACE showed that the risk of non-fatal myocardial infarction or heart attack was reduced by 28% compared to placebo (HR: 0.72; 95% confidence interval: 0.61; 0.85), the risk of cardiovascular death was reduced by 15% (HR: 0.85; 95% confidence interval: 0.71; 1.01, not statistically significant over the length of the trial) and the risk of non-fatal stroke was reduced by 7% compared to placebo (HR: 0.93; 95% confidence interval: 0.74;1.15, not statistically significant over the length of the trial).1 In addition, beneficial effects were seen consistently across measured cardiovascular endpoints.1 The confirmatory secondary endpoints showed that the risk of composite heart failure events, comprising cardiovascular death, urgent heart failure visits and hospitalisations, was reduced by 18% compared to placebo (HR: 0.82; 95% confidence interval: 0.71; 0.96) and the risk of death from any cause was reduced by 19% compared to placebo (HR: 0.81; 95% confidence interval: 0.71; 0.93).1 As the result on cardiovascular death was not statistically significant over the length of the trial, the remaining secondary confirmatory endpoints were not tested for superiority due to hierarchical testing.1
The supportive secondary endpoints also showed beneficial effects of semaglutide 2.4 mg on other cardiovascular risk factors, including lowering blood pressure, cholesterol and blood sugar levels.1 While the trial was not designed as a weight loss trial, participants in the trial who received semaglutide still lost an average of 9.4% of total body weight which was sustained throughout the trial.1
"This landmark study builds on more than 20 years of research in obesity, a serious chronic disease associated with severe co-morbidities and outcomes. The results from SELECT will be instrumental in changing the way we perceive and treat obesity," said Martin Lange, executive vice president and head of Development at Novo Nordisk. "These results represent a pivotal moment for people with obesity and the global scientific community as we look ahead to a new era of managing obesity and potentially reducing cardiovascular risks with semaglutide 2.4 mg."
In the trial, semaglutide 2.4 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 2.4 mg trials.1,7,8
Novo Nordisk has filed for a label update of Wegovy® in the US and EU to include an indication for risk reduction of major adverse cardiovascular events in adults with a BMI of ≥27 kg/m2 and established cardiovascular disease. A decision is expected in 2024. The Food and Drug Administration (FDA) recently granted priority review for the addition of the SELECT data to the label for Wegovy® in the US.
About SELECT
SELECT (Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity) was a randomised, double-blind, parallel-group, placebo-controlled trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo as an adjunct to standard of care for reducing the risk of MACE in people with established CVD with overweight or obesity with no prior history of diabetes.1
People included in the trial were aged ≥45 years with a BMI ≥27 kg/m2. Baseline demographics by age group show that 24% were aged 45-54, 38% aged 55-64, 30% aged 65-74 and 8% aged 75 years plus. By race or ethnicity, 84% of trial participants were white, 10% Hispanic or Latino, 8% Asian, 4% black and 3% other. The split between male and female participants was 72% and 28% respectively.1
The trial enrolled 17,604 adults and has been conducted in 41 countries at more than 800 investigator sites. SELECT was initiated in 2018 and is the largest trial Novo Nordisk has ever conducted.1
About Wegovy® (semaglutide 2.4 mg)
Wegovy® (once-weekly subcutaneous semaglutide 2.4 mg) is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with a BMI of 30 kg/m2 or greater (obesity), adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, and paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity)8. Wegovy® is launched in the US, Denmark, Norway, Germany, UK, Iceland and Switzerland.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 61,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Contact for further information:
Media:
Ambre James-Brown
+45 3079 9289
[email protected]
Elizabeth DeLuca (US)
+1 609 580 9868
[email protected]
Investors:
Daniel Muusmann Bohsen
+45 3075 2175
[email protected]
Jacob Martin Wiborg Rode
+45 3075 5956
[email protected]
David Heiberg Landsted
+45 3077 6915
[email protected]
Mark Joseph Root (US)
+1 848 213 3219
[email protected]
Sina Meyer
+45 3075 6656 [email protected]
Frederik Taylor Pitter
+45 3075 8259
[email protected]
Semaglutide 2.4 mg delivered a statistically significant 20% risk reduction in major adverse cardiovascular events (MACE) with risk reductions demonstrated consistently across age, gender, ethnicity and starting body mass index (BMI).
Beneficial effects were seen consistently across measured cardiovascular endpoints with semaglutide 2.4 mg.
Risk reductions in MACE were evident soon after initiation, suggesting an effect of semaglutide 2.4 mg beyond weight loss alone.
Bagsværd, Denmark, 11 November 2023 - Novo Nordisk today announced the primary results of SELECT, its landmark phase 3 cardiovascular outcomes trial investigating the effects of once-weekly semaglutide 2.4 mg (Wegovy®) in adults with established cardiovascular disease (CVD) and overweight or obesity without diabetes at the American Heart Association (AHA) annual Scientific Sessions in Philadelphia. The data were simultaneously published in the New England Journal of Medicine (NEJM). 1
Previously reported top-line results showed semaglutide 2.4 mg delivered a statistically significant 20% risk reduction in MACE over a period of up to five years versus placebo (HR: 0.80; 95% confidence interval: 0.72; 0.90, p<0.001). Today's findings showed that risk reductions in MACE were achieved regardless of age, gender, ethnicity and starting body mass index (BMI).1 The results also demonstrated that the beneficial effects in MACE risk reduction were evident soon after treatment initiation, suggesting an effect that is more rapid than what would be expected if the cardiovascular effects were entirely mediated with the effects of semaglutide 2.4 mg on body weight reduction.1 This suggests that weight loss alone may not fully explain the benefits of semaglutide 2.4 mg in reducing the risk of MACE.1
Every year almost 18 million people die from CVD which is the leading cause of disability and death worldwide.2,3,4 While cardiovascular mortality has decreased over the past two decades, obesity-related cardiovascular deaths have increased significantly.5 Obesity leads to cardiovascular morbidity and mortality and is associated with risk factors such as high blood pressure and inflammation.3,6
"For the first time, we have evidence that semaglutide 2.4 mg improves cardiovascular outcomes in at-risk patients with BMI of 27 and above with established CVD, without diabetes," said Dr Michael Lincoff, lead study author, vice chair for research in the Cleveland Clinic Department of Cardiovascular Medicine, and a paid consultant for Novo Nordisk. "The three-point MACE risk reduction observed in SELECT suggests the potential for a new option in obesity treatment, addressing some of the leading causes of preventable death worldwide."
Analyses of the three components in MACE showed that the risk of non-fatal myocardial infarction or heart attack was reduced by 28% compared to placebo (HR: 0.72; 95% confidence interval: 0.61; 0.85), the risk of cardiovascular death was reduced by 15% (HR: 0.85; 95% confidence interval: 0.71; 1.01, not statistically significant over the length of the trial) and the risk of non-fatal stroke was reduced by 7% compared to placebo (HR: 0.93; 95% confidence interval: 0.74;1.15, not statistically significant over the length of the trial).1 In addition, beneficial effects were seen consistently across measured cardiovascular endpoints.1 The confirmatory secondary endpoints showed that the risk of composite heart failure events, comprising cardiovascular death, urgent heart failure visits and hospitalisations, was reduced by 18% compared to placebo (HR: 0.82; 95% confidence interval: 0.71; 0.96) and the risk of death from any cause was reduced by 19% compared to placebo (HR: 0.81; 95% confidence interval: 0.71; 0.93).1 As the result on cardiovascular death was not statistically significant over the length of the trial, the remaining secondary confirmatory endpoints were not tested for superiority due to hierarchical testing.1
The supportive secondary endpoints also showed beneficial effects of semaglutide 2.4 mg on other cardiovascular risk factors, including lowering blood pressure, cholesterol and blood sugar levels.1 While the trial was not designed as a weight loss trial, participants in the trial who received semaglutide still lost an average of 9.4% of total body weight which was sustained throughout the trial.1
"This landmark study builds on more than 20 years of research in obesity, a serious chronic disease associated with severe co-morbidities and outcomes. The results from SELECT will be instrumental in changing the way we perceive and treat obesity," said Martin Lange, executive vice president and head of Development at Novo Nordisk. "These results represent a pivotal moment for people with obesity and the global scientific community as we look ahead to a new era of managing obesity and potentially reducing cardiovascular risks with semaglutide 2.4 mg."
In the trial, semaglutide 2.4 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 2.4 mg trials.1,7,8
Novo Nordisk has filed for a label update of Wegovy® in the US and EU to include an indication for risk reduction of major adverse cardiovascular events in adults with a BMI of ≥27 kg/m2 and established cardiovascular disease. A decision is expected in 2024. The Food and Drug Administration (FDA) recently granted priority review for the addition of the SELECT data to the label for Wegovy® in the US.
About SELECT
SELECT (Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity) was a randomised, double-blind, parallel-group, placebo-controlled trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo as an adjunct to standard of care for reducing the risk of MACE in people with established CVD with overweight or obesity with no prior history of diabetes.1
People included in the trial were aged ≥45 years with a BMI ≥27 kg/m2. Baseline demographics by age group show that 24% were aged 45-54, 38% aged 55-64, 30% aged 65-74 and 8% aged 75 years plus. By race or ethnicity, 84% of trial participants were white, 10% Hispanic or Latino, 8% Asian, 4% black and 3% other. The split between male and female participants was 72% and 28% respectively.1
The trial enrolled 17,604 adults and has been conducted in 41 countries at more than 800 investigator sites. SELECT was initiated in 2018 and is the largest trial Novo Nordisk has ever conducted.1
About Wegovy® (semaglutide 2.4 mg)
Wegovy® (once-weekly subcutaneous semaglutide 2.4 mg) is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with a BMI of 30 kg/m2 or greater (obesity), adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, and paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity)8. Wegovy® is launched in the US, Denmark, Norway, Germany, UK, Iceland and Switzerland.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 61,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Contact for further information:
Media:
Ambre James-Brown
+45 3079 9289
[email protected]
Elizabeth DeLuca (US)
+1 609 580 9868
[email protected]
Investors:
Daniel Muusmann Bohsen
+45 3075 2175
[email protected]
Jacob Martin Wiborg Rode
+45 3075 5956
[email protected]
David Heiberg Landsted
+45 3077 6915
[email protected]
Mark Joseph Root (US)
+1 848 213 3219
[email protected]
Sina Meyer
+45 3075 6656 [email protected]
Frederik Taylor Pitter
+45 3075 8259
[email protected]
11/11 2023 15:53 ProInvestorNEWS 11
116673 "Select data er ude. Død forårsaget af komplikationer med hjertet blev risikoen reduceret med 15%. Ikke dødelig blodprop i hvertet reduceret med 28%. Ikke dødelig slagtilfælde reduceret med 7%. Hjertesvigt reduceret med 18% samt død uanset årsag reduceret med 19%
Forværing af nyrefunktion reduceret med 22%
Risikoen for at udvikle diabetes reduceret med 73%
Risikoen for at udvikle prædiabetes reduceret med 67%
Det generelle inflammationsniveau reduceret med 39%
Det er bla indvirkning på reducering af inflammation man mener kan have indvirkning på demens (Novo kører 2 ret store fase 3 studier mod Demens/AD)
Ikke alle de sekundære målinger har vist signifikans... Men det er på tværs af patienter og endpoints virkelig flotte data. Og det vil helt sikkert lette forhandlingerne med div myndigheder og forsikringsselskaber. Altså et rigtig godt kort og timing mod LLYs nu godkendte Zepbound.
Kilde: Troldmanden.... https://www.proinvestor.com/chathistory/-124/novo
Forværing af nyrefunktion reduceret med 22%
Risikoen for at udvikle diabetes reduceret med 73%
Risikoen for at udvikle prædiabetes reduceret med 67%
Det generelle inflammationsniveau reduceret med 39%
Det er bla indvirkning på reducering af inflammation man mener kan have indvirkning på demens (Novo kører 2 ret store fase 3 studier mod Demens/AD)
Ikke alle de sekundære målinger har vist signifikans... Men det er på tværs af patienter og endpoints virkelig flotte data. Og det vil helt sikkert lette forhandlingerne med div myndigheder og forsikringsselskaber. Altså et rigtig godt kort og timing mod LLYs nu godkendte Zepbound.
Kilde: Troldmanden.... https://www.proinvestor.com/chathistory/-124/novo
12/11 2023 12:58 ProInvestorNEWS 3116681 Novo-direktør om hjerte-kar-data: Et fantastisk redskab når der skal forhandles tilskud
12.11.2023 07.13 • MarketWire •
Novo Nordisks store hjerte-kar-studie med vægttabsmidlet Wegovy har vist særdeles robuste data og giver Novo gode kort på hånden, når der skal forhandles om tilskud og dækning med sygekasserne.
Det er et af budskaberne på et analytikermøde natten til søndag fra Martin Holst Lange, koncerndirektør i Novo Nordisk med ansvar for udvikling af nye lægemidler.
- Det er et fantastisk redskab at have Select, når vi drøfter og forhandler med betalere i årene fremover. For de vil selvfølgelig spørge, om det her bare handler om tab af nogle kilo, og det klare svar er: "nej", siger Martin Holst Lange.
Han beskriver datapakken fra hjerte-kar-studiet som et højdepunkt.
- Jeg har arbejdet med det her i 22 år, og jeg har aldrig set så stor konsistens på tværs af alt, hvad vi har kigget på.
EFFEKT PÅ TVÆRS
Novos hjerte-kar-studie ved navn Select er gennemført i 17.604 overvægtige voksne over 45 år med konstateret hjerte-kar-sygdom, men uden diabetes.
Resultaterne viser overordnet, at Wegovy reducerer risikoen for alvorlige hjerte-kar-hændelser, det vil sige blodprop, slagtilfælde og hjerte-kar-død med 20 pct.
Men underanalyserne underbygger desuden, at Wegovy har effekt på alle parametre, som Novo har kigget på.
Det gælder blandt andet blodprop, slagtilfælde, hjerte-kar-død, dødsfald af enhver årsag, hospitalsindlæggelser, kronisk nyresygdom og risikoen for udvikling diabetes.
Samtidig gælder beskyttelsen mod alvorlige hjerte-kar-hændelser uafhængig af alder, køn eller etnisk oprindelse og også, hvor overvægtige folk var, da de indledte behandlingen.
Ikke alle underparametre viser statistisk signifikans, men det har studiet heller ikke været designet til at vise.
Derfor er det også bemærkelsesværdigt, at Wegovy giver anledning til en reduktion i risikoen for blodpropper på 28 pct. Det er statistisk højsignifikant, siger Martin Holst Lange.
Antallet af dødsfald som følge hjerte-kar-død blev reduceret med 15 pct., mens antallet af slagtilfælde blev reduceret med 7 pct. Her er var reduktionen dog ikke statistisk signifikant. Det var reduktionen i dødsfald af enhver art på 19 pct. til gengæld.
Martin Holst Lange hæfter sig desuden ved, at vægttabet, som Wegovy gav anledning til i studiet på omkring 10 pct., blev fastholdt igennem fire år.
- Det er særligt glædeligt for mig, for det er første gang jeg har set data over fire år, siger han.
REDUCERER RISIKOEN FOR AT UDVIKLE DIABETES
En anden fordel, som skal undersøges nærmere er, om Wegovy kan forebygge udvikling af diabetes også på den længere bane.
Cirka to tredjedele af deltagerne i Select-studiet havde prædiabetes, da de startede behandlingen med Wegovy, og var altså i farezonen for at udvikle diabetes.
Men gruppen af overvægtige, der fik Novos vægttabsmiddel, havde 73 pct. lavere sandsynlighed for at udvikle diabetes sammenlignet med gruppen, der fik placebo.
Der er dog tale om en forebyggelse, som lægemiddelmyndighederne næppe endnu vil anerkende, før de har set større bevis for, at bedringen varer ved.
Blandt andet til det formål vil Novo i op til ti år følge deltagere i Select i studiet Select Life, hvor deltagerne ikke længere vil modtage den medicin, de fik i Select-studiet, men alene blive behandlet, som de normalt ville af deres læge.
Hvornår Novo har tilstrækkelige data til at overbevise myndighederne om, at effekten varer ved, er usikkert, siger Robin Evers, der er direktør i Novo med ansvar for sikkerhed og interaktion med sundhedsmyndighederne. Tidligere har der været spekuleret i omkring et års data.
- Jeg tror, at det, myndighederne og særligt den amerikanske lægemiddelstyrelse har talt om, er en lang opfølgningsperiode uden lægemidlet for at se, om der kommer et tilbagefald. Vi vil selvfølgelig fortsætte med at følge udfaldene i dette studie og sammenholde med andre datasæt, som vi laver. Men det står ikke helt klart, hvad den amerikanske lægemiddelstyrelse vil kræve, siger Robin Evers.
I forhold til at få godkendt effekt af Wegovy i behandling af hjertesvigt er Novo på vej med yderligere studier. Desuden
Novo har til gengæld allerede ansøgt både de amerikanske og europæiske sundhedsmyndigheder om en opdatering af indlægssedlen for Wegovy med hjerte-kar-fordelen. Der ventes en tilbagemelding fra myndighederne i 2024.
.\˙ MarketWire
12.11.2023 07.13 • MarketWire •
Novo Nordisks store hjerte-kar-studie med vægttabsmidlet Wegovy har vist særdeles robuste data og giver Novo gode kort på hånden, når der skal forhandles om tilskud og dækning med sygekasserne.
Det er et af budskaberne på et analytikermøde natten til søndag fra Martin Holst Lange, koncerndirektør i Novo Nordisk med ansvar for udvikling af nye lægemidler.
- Det er et fantastisk redskab at have Select, når vi drøfter og forhandler med betalere i årene fremover. For de vil selvfølgelig spørge, om det her bare handler om tab af nogle kilo, og det klare svar er: "nej", siger Martin Holst Lange.
Han beskriver datapakken fra hjerte-kar-studiet som et højdepunkt.
- Jeg har arbejdet med det her i 22 år, og jeg har aldrig set så stor konsistens på tværs af alt, hvad vi har kigget på.
EFFEKT PÅ TVÆRS
Novos hjerte-kar-studie ved navn Select er gennemført i 17.604 overvægtige voksne over 45 år med konstateret hjerte-kar-sygdom, men uden diabetes.
Resultaterne viser overordnet, at Wegovy reducerer risikoen for alvorlige hjerte-kar-hændelser, det vil sige blodprop, slagtilfælde og hjerte-kar-død med 20 pct.
Men underanalyserne underbygger desuden, at Wegovy har effekt på alle parametre, som Novo har kigget på.
Det gælder blandt andet blodprop, slagtilfælde, hjerte-kar-død, dødsfald af enhver årsag, hospitalsindlæggelser, kronisk nyresygdom og risikoen for udvikling diabetes.
Samtidig gælder beskyttelsen mod alvorlige hjerte-kar-hændelser uafhængig af alder, køn eller etnisk oprindelse og også, hvor overvægtige folk var, da de indledte behandlingen.
Ikke alle underparametre viser statistisk signifikans, men det har studiet heller ikke været designet til at vise.
Derfor er det også bemærkelsesværdigt, at Wegovy giver anledning til en reduktion i risikoen for blodpropper på 28 pct. Det er statistisk højsignifikant, siger Martin Holst Lange.
Antallet af dødsfald som følge hjerte-kar-død blev reduceret med 15 pct., mens antallet af slagtilfælde blev reduceret med 7 pct. Her er var reduktionen dog ikke statistisk signifikant. Det var reduktionen i dødsfald af enhver art på 19 pct. til gengæld.
Martin Holst Lange hæfter sig desuden ved, at vægttabet, som Wegovy gav anledning til i studiet på omkring 10 pct., blev fastholdt igennem fire år.
- Det er særligt glædeligt for mig, for det er første gang jeg har set data over fire år, siger han.
REDUCERER RISIKOEN FOR AT UDVIKLE DIABETES
En anden fordel, som skal undersøges nærmere er, om Wegovy kan forebygge udvikling af diabetes også på den længere bane.
Cirka to tredjedele af deltagerne i Select-studiet havde prædiabetes, da de startede behandlingen med Wegovy, og var altså i farezonen for at udvikle diabetes.
Men gruppen af overvægtige, der fik Novos vægttabsmiddel, havde 73 pct. lavere sandsynlighed for at udvikle diabetes sammenlignet med gruppen, der fik placebo.
Der er dog tale om en forebyggelse, som lægemiddelmyndighederne næppe endnu vil anerkende, før de har set større bevis for, at bedringen varer ved.
Blandt andet til det formål vil Novo i op til ti år følge deltagere i Select i studiet Select Life, hvor deltagerne ikke længere vil modtage den medicin, de fik i Select-studiet, men alene blive behandlet, som de normalt ville af deres læge.
Hvornår Novo har tilstrækkelige data til at overbevise myndighederne om, at effekten varer ved, er usikkert, siger Robin Evers, der er direktør i Novo med ansvar for sikkerhed og interaktion med sundhedsmyndighederne. Tidligere har der været spekuleret i omkring et års data.
- Jeg tror, at det, myndighederne og særligt den amerikanske lægemiddelstyrelse har talt om, er en lang opfølgningsperiode uden lægemidlet for at se, om der kommer et tilbagefald. Vi vil selvfølgelig fortsætte med at følge udfaldene i dette studie og sammenholde med andre datasæt, som vi laver. Men det står ikke helt klart, hvad den amerikanske lægemiddelstyrelse vil kræve, siger Robin Evers.
I forhold til at få godkendt effekt af Wegovy i behandling af hjertesvigt er Novo på vej med yderligere studier. Desuden
Novo har til gengæld allerede ansøgt både de amerikanske og europæiske sundhedsmyndigheder om en opdatering af indlægssedlen for Wegovy med hjerte-kar-fordelen. Der ventes en tilbagemelding fra myndighederne i 2024.
.\˙ MarketWire
