Amsterdam, Netherlands, 25 August 2023 - Novo Nordisk today announced results from the phase 3 STEP HFpEF trial showing that compared with placebo, once-weekly semaglutide 2.4 mg led to large reductions in heart failure-related symptoms, physical limitations and improvements in exercise function, and resulted in greater weight loss in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.1
HFpEF comprises roughly half of all heart failure cases2 and is associated with a high burden of symptoms and physical limitations affecting daily life,3 including fatigue, shortness of breath, reduced ability to exercise, and swelling of extremities. The majority (80%) of people with HFpEF also live with overweight or obesity, which is linked to a higher burden of symptoms, worse physical function and lower quality of life.4-6
The findings, presented today at the European Society of Cardiology (ESC) Congress in Amsterdam, Netherlands and published simultaneously in the New England Journal of Medicine, show large improvement in patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), measuring the symptoms and physical limitations of HFpEF.
"As clinicians, we have limited treatment options to offer our patients living with HFpEF and obesity. Yet this is a condition that seriously impacts patients' day-to-day experience, due to debilitating symptoms and functional limitations," said Dr Mikhail Kosiborod, lead study investigator and cardiologist at Saint Luke's Mid America Heart Institute, Kansas City, USA. "Today's news heralds a possible fundamental paradigm shift in how cardiologists approach HFpEF in people with obesity. It's gratifying to be able to share important evidence that has a potential to change the future clinical management of this vulnerable patient population."
The mean change in the KCCQ-CSS was a 16.6-point increase at 52 weeks with semaglutide 2.4 mg vs 8.7 points with placebo, leading to an estimated treatment difference of 7.8 points (p<0.001). Mean change in body weight was 13.3% reduction with semaglutide 2.4 mg vs. 2.6% reduction with placebo, leading to an estimated treatment difference of 10.7% weight reduction (p<0.001).1
STEP HFpEF also demonstrated a mean increase in 6-Minute Walking Distance (6MWD) of 21.5 metres at 52 weeks with semaglutide vs. 1.2 metres with placebo leading to an estimated treatment difference of 20.3 meters (p<0.001).1 Semaglutide also reduced inflammation, as measured by high-sensitivity C-reactive protein (hsCRP).1
The safety profile of semaglutide 2.4 mg was consistent with previous studies; fewer serious adverse events were observed with semaglutide 2.4 mg compared with placebo.1
"We are delighted with the results from STEP HFpEF, which show that semaglutide 2.4 mg is able to ease the disease burden for people with HFpEF and obesity in a substantial way," said Martin Lange, executive vice president and head of Development at Novo Nordisk. "These results come just weeks after the topline findings of our semaglutide 2.4 mg and cardiovascular outcomes trial were announced and reinforce the potential of semaglutide 2.4 mg to enhance cardiovascular care, beyond weight management. We look forward to working closely with the clinical community and regulators to help realise this potential over the coming months."
About heart failure with preserved ejection fraction (HFpEF) and obesity
There are 64 million people living with heart failure worldwide.7 HFpEF is now the most common form of heart failure, comprising approximately 50% of all cases.2,8 Importantly, 80% of people with HFpEF also live with overweight or obesity.4
Obesity is rapidly increasing and is considered a key driver in the development and progression of HFpEF.2,5 Despite therapeutic advances in HFpEF, significant unmet needs persist, and it has been hypothesised that phenotype-specific treatments may provide clinical benefits.5 People with HFpEF and obesity have a high mortality rate, high risk of hospitalisation, and high burden of debilitating symptoms, physical and social limitations and poor quality of life.2,6
About STEP HFpEF and STEP HFpEF-DM
The primary objective of STEP HFpEF trial was to investigate the effects of semaglutide 2.4 mg subcutaneous once-weekly on symptoms, physical function, and body weight compared with placebo in patients with HFpEF and obesity. STEP HFpEF included 529 people with symptomatic HFpEF (ejection fraction ≥45%) and obesity (BMI ≥30 kg/m2). Dual primary endpoints were change in KCCQ-CSS from baseline to week 52 and change in body weight from baseline to week 52; with key secondary endpoints of change in 6MWD from baseline to week 52, hierarchical composite endpoint (all cause death, heart failure events, difference in KCCQ-CSS change and difference in 6MWD change from baseline to week 52), and change in C-reactive protein from baseline (screening) to week 52.
The ongoing STEP HFpEF-DM trial - another study of HFpEF and obesity in people with type 2 diabetes - is to be included in the regulatory submission. STEP HFpEF-DM is expected to complete in Q4 2023, and subject to positive outcomes Novo Nordisk expects to file for approval of Wegovy® label update in the US and EU in the first half of 2024.
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 pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity). Wegovy® is launched in the US, Denmark, Norway and Germany.
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 59,000 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
abmo@novonordisk.com
Natalia Salomao Abrahao (US)
+1 848 304 1027
niaa@novonordisk.com
Investors:
Daniel Muusmann Bohsen
+45 3075 2175
dabo@novonordisk.com
David Heiberg Landsted
+45 3077 6915
dhel@novonordisk.com
HFpEF comprises roughly half of all heart failure cases2 and is associated with a high burden of symptoms and physical limitations affecting daily life,3 including fatigue, shortness of breath, reduced ability to exercise, and swelling of extremities. The majority (80%) of people with HFpEF also live with overweight or obesity, which is linked to a higher burden of symptoms, worse physical function and lower quality of life.4-6
The findings, presented today at the European Society of Cardiology (ESC) Congress in Amsterdam, Netherlands and published simultaneously in the New England Journal of Medicine, show large improvement in patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), measuring the symptoms and physical limitations of HFpEF.
"As clinicians, we have limited treatment options to offer our patients living with HFpEF and obesity. Yet this is a condition that seriously impacts patients' day-to-day experience, due to debilitating symptoms and functional limitations," said Dr Mikhail Kosiborod, lead study investigator and cardiologist at Saint Luke's Mid America Heart Institute, Kansas City, USA. "Today's news heralds a possible fundamental paradigm shift in how cardiologists approach HFpEF in people with obesity. It's gratifying to be able to share important evidence that has a potential to change the future clinical management of this vulnerable patient population."
The mean change in the KCCQ-CSS was a 16.6-point increase at 52 weeks with semaglutide 2.4 mg vs 8.7 points with placebo, leading to an estimated treatment difference of 7.8 points (p<0.001). Mean change in body weight was 13.3% reduction with semaglutide 2.4 mg vs. 2.6% reduction with placebo, leading to an estimated treatment difference of 10.7% weight reduction (p<0.001).1
STEP HFpEF also demonstrated a mean increase in 6-Minute Walking Distance (6MWD) of 21.5 metres at 52 weeks with semaglutide vs. 1.2 metres with placebo leading to an estimated treatment difference of 20.3 meters (p<0.001).1 Semaglutide also reduced inflammation, as measured by high-sensitivity C-reactive protein (hsCRP).1
The safety profile of semaglutide 2.4 mg was consistent with previous studies; fewer serious adverse events were observed with semaglutide 2.4 mg compared with placebo.1
"We are delighted with the results from STEP HFpEF, which show that semaglutide 2.4 mg is able to ease the disease burden for people with HFpEF and obesity in a substantial way," said Martin Lange, executive vice president and head of Development at Novo Nordisk. "These results come just weeks after the topline findings of our semaglutide 2.4 mg and cardiovascular outcomes trial were announced and reinforce the potential of semaglutide 2.4 mg to enhance cardiovascular care, beyond weight management. We look forward to working closely with the clinical community and regulators to help realise this potential over the coming months."
About heart failure with preserved ejection fraction (HFpEF) and obesity
There are 64 million people living with heart failure worldwide.7 HFpEF is now the most common form of heart failure, comprising approximately 50% of all cases.2,8 Importantly, 80% of people with HFpEF also live with overweight or obesity.4
Obesity is rapidly increasing and is considered a key driver in the development and progression of HFpEF.2,5 Despite therapeutic advances in HFpEF, significant unmet needs persist, and it has been hypothesised that phenotype-specific treatments may provide clinical benefits.5 People with HFpEF and obesity have a high mortality rate, high risk of hospitalisation, and high burden of debilitating symptoms, physical and social limitations and poor quality of life.2,6
About STEP HFpEF and STEP HFpEF-DM
The primary objective of STEP HFpEF trial was to investigate the effects of semaglutide 2.4 mg subcutaneous once-weekly on symptoms, physical function, and body weight compared with placebo in patients with HFpEF and obesity. STEP HFpEF included 529 people with symptomatic HFpEF (ejection fraction ≥45%) and obesity (BMI ≥30 kg/m2). Dual primary endpoints were change in KCCQ-CSS from baseline to week 52 and change in body weight from baseline to week 52; with key secondary endpoints of change in 6MWD from baseline to week 52, hierarchical composite endpoint (all cause death, heart failure events, difference in KCCQ-CSS change and difference in 6MWD change from baseline to week 52), and change in C-reactive protein from baseline (screening) to week 52.
The ongoing STEP HFpEF-DM trial - another study of HFpEF and obesity in people with type 2 diabetes - is to be included in the regulatory submission. STEP HFpEF-DM is expected to complete in Q4 2023, and subject to positive outcomes Novo Nordisk expects to file for approval of Wegovy® label update in the US and EU in the first half of 2024.
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 pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity). Wegovy® is launched in the US, Denmark, Norway and Germany.
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 59,000 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
abmo@novonordisk.com
Natalia Salomao Abrahao (US)
+1 848 304 1027
niaa@novonordisk.com
Investors:
Daniel Muusmann Bohsen
+45 3075 2175
dabo@novonordisk.com
David Heiberg Landsted
+45 3077 6915
dhel@novonordisk.com
25/8 2023 11:47 ProInvestorNEWS 5
114935 Novos vægttabsmiddel Wegovy dæmper symptomerne i overvægtige patienter med hjerteinsufficiens, eller hjertesvigt med bevaret pumpefunktion.
Det fremgår af et studie, der er offentliggjort i det videnskabelige tidsskrift New England Journal of Medicine.
Typiske symptomer for patienter med hjerteinsufficiens er åndenød og træthed, særligt ved anstrengelse.
Tidligere i august offentliggjorde Novo også positive resultater fra et stort hjerte-kar-studie med Wegovy i overvægtige med etableret hjerte-kar-sygdom, der viste, at Wegovy reducerer risikoen for alvorlige hjerte-kar-tilfælde som blodprop, slagtilfælde og dødsfald med 20 pct. sammenlignet med placebo - eller snydemedicin.
.\˙ MarketWire
Det fremgår af et studie, der er offentliggjort i det videnskabelige tidsskrift New England Journal of Medicine.
Typiske symptomer for patienter med hjerteinsufficiens er åndenød og træthed, særligt ved anstrengelse.
Tidligere i august offentliggjorde Novo også positive resultater fra et stort hjerte-kar-studie med Wegovy i overvægtige med etableret hjerte-kar-sygdom, der viste, at Wegovy reducerer risikoen for alvorlige hjerte-kar-tilfælde som blodprop, slagtilfælde og dødsfald med 20 pct. sammenlignet med placebo - eller snydemedicin.
.\˙ MarketWire
25/8 2023 12:51 troldmanden 10114936 På CC efter halvårsregnskabet, der sagde novo faktisk at under normale omstændigheder, så ville HFpef forsøget få enormt meget fokus, fordi de mener det er banebrydende i et segment der pt er dårligt medicineret.
Næste sætning var så at med den fokus der allerede var på ozempic/wegovy og de ekstremt pressede supply så druknede det studie.
Der bliver bare ved og ved med at komme virkelig flotte data i nye store relativ ubehandlede patientgrupper.
Nu er amerikanerne dem der betaler den højeste pris. Men som tidligere nævnt så tog det 6 mdr i DK at nå op på én procent af den danske befolkning på wegovy. I US vil blot én procent af befolkningen, svare til ca 200 mia dkk om året.
Det ER crszy tal
Næste sætning var så at med den fokus der allerede var på ozempic/wegovy og de ekstremt pressede supply så druknede det studie.
Der bliver bare ved og ved med at komme virkelig flotte data i nye store relativ ubehandlede patientgrupper.
Nu er amerikanerne dem der betaler den højeste pris. Men som tidligere nævnt så tog det 6 mdr i DK at nå op på én procent af den danske befolkning på wegovy. I US vil blot én procent af befolkningen, svare til ca 200 mia dkk om året.
Det ER crszy tal
"- Vi har at gøre med måske en milliard patienter rundt om i verden, siger Lars Fruergaard Jørgensen "
https://www.proinvestor.com/investornyt/1040296/topchef-novo-vil-adressere-social-ulighed-i-dialog-om-tilskudsordninger
https://www.proinvestor.com/investornyt/1040296/topchef-novo-vil-adressere-social-ulighed-i-dialog-om-tilskudsordninger
27/8 2023 07:28 VærKritisk 8114965 Snart vil de her fedmeprodukter blive produceret i mængder der kun overgåes af cornflakes. På den konto så tror jeg man må forudse, at priserne på et tidspunkt kommer til at falde, ret meget endda. Også fordi der fra både Europa og især usa vil komme et masssivt politisk pres efterhånden som producenternes profitter når højere op end Andreas Mogensen nogensinde har været.
29/8 2023 10:52 troldmanden 5115003 Ja prisen, særligt i US kommer helt sikkert betydeligt ned. Men det bliver ikke de næste 2-3 år.
Nedenstående tråd sætter lidt flere data på størrelse af markedet
https://www.proinvestor.com/boards/115000/
Nedenstående tråd sætter lidt flere data på størrelse af markedet
https://www.proinvestor.com/boards/115000/
29/8 2023 13:04 VærKritisk 4115013 Det har du nok ret i. Efterspørgslen efter disse produkter er dog så enorm, at den kan true sundhedsbudgetterne for ikke ligefrem at sige de nationale økonomier, så det kan føre til en total omlægning af tilskudsordningerne, simpelthen fordi politikerne ikke har noget andet vælg. Ikke sikkert det sker, men jeg mener der en reel risiko for at Selskabernes grådighed kan ramme dem selv lige i hovedet, hvis ikke de passer på.
Det "løses" meget nemt. Produkterne bliver simpelthen ikke tilskudsberettiget. Det bliver udenfor de offentlige og forsikrings kasserne, medmindre der er helt særlige grunde som tæller for det. Altså ekstrem fedme koblet op på en række andre sygdomme...
29/8 2023 13:35 VærKritisk 2115017 Decideret nemme løsninger tror jeg nu ikke så meget på. I usa måske, men andre steder kan man nok ikke udelukke, at der kan komme et kraftigt folkeligt pres for at få dette omfattet af tilskud hvilende på feks argumenter om social ulighed etc..or whatever. Det kan også bare være ekstra beskatning af ekstraordinært høje profitter..., som jo er en ny ide, politikerne sagtens kan finde frem igen. Man kan forestille sig så meget, men Novo begår en fejl hvis de tror de er urørlige...som jeg ser det. Nok fra mig om dette emne. Hav en god dag
29/8 2023 13:52 troldmanden 4115018 Hverken i DK eller Norge er der tilskud til wegovy. Mener heller ikke der er endnu i Tyskland. US er mere spredt. Nogle får mens andre selv betaler.
Som skrevet andetsted så tror jeg det bliver gruppen bmi40+ med følgesygdomme man forsøger at få tilskud til. Alle andre skal selv betale.
Dertil har de enkelte lande inkl DK jo også masser af muligheder for at fortage justerede tilskud betingelser. Herunder den andel borgeren selv skal betale.
Men alt det her er helt uden betydning for wegovy salg 2+ år frem
Som skrevet andetsted så tror jeg det bliver gruppen bmi40+ med følgesygdomme man forsøger at få tilskud til. Alle andre skal selv betale.
Dertil har de enkelte lande inkl DK jo også masser af muligheder for at fortage justerede tilskud betingelser. Herunder den andel borgeren selv skal betale.
Men alt det her er helt uden betydning for wegovy salg 2+ år frem
29/8 2023 07:00 Helge Larsen/PI-redaktør 3114997 Novo Nordisks fedmemedicin kan sende milliardregning for tilskud til staten
29/8 07:22
Det vil koste staten adskillige milliarder, hvis fedmemidler som Novo Nordisks Wegovy fremover skal være en af den offentlige tilskudsordning.
Det fremgår af et svar fra sundhedsminister Sophie Løhde (V) til Folketingets Sundhedsudvalg.
Omkring 900.000 danskere vurderes ifølge Sundhedsministeriet og Sundhedsstyrelsen at være svært overvægtige med et BMI, body mass index, på over 30, og det er den gruppe, som ministeren har set nærmere på.
- Hvis alle i denne gruppe fik offentligt tilskud til behandling med Wegovy, ville det medføre regionale tilskudsudgifter imellem 23,9 og 27,9 mia. kr., fremgår det af svaret fra Sophie Løhde.
Den præcise udgift afhænger dog i sidste ende af, hvilke udgifter patienterne i øvrigt har til tilskudsberettiget medicin, og dermed hvor tæt de er på loftet for maksimal egenbetaling. Udregningen er baseret på tal for medicinpriser og tilskud i 2023.
Med et BMI over 30 anses man for at være svært overvægtig, mens et BMI i intervallet 18,5-24,9 anses for at være normalt.
.\˙ MarketWire
29/8 07:22
Det vil koste staten adskillige milliarder, hvis fedmemidler som Novo Nordisks Wegovy fremover skal være en af den offentlige tilskudsordning.
Det fremgår af et svar fra sundhedsminister Sophie Løhde (V) til Folketingets Sundhedsudvalg.
Omkring 900.000 danskere vurderes ifølge Sundhedsministeriet og Sundhedsstyrelsen at være svært overvægtige med et BMI, body mass index, på over 30, og det er den gruppe, som ministeren har set nærmere på.
- Hvis alle i denne gruppe fik offentligt tilskud til behandling med Wegovy, ville det medføre regionale tilskudsudgifter imellem 23,9 og 27,9 mia. kr., fremgår det af svaret fra Sophie Løhde.
Den præcise udgift afhænger dog i sidste ende af, hvilke udgifter patienterne i øvrigt har til tilskudsberettiget medicin, og dermed hvor tæt de er på loftet for maksimal egenbetaling. Udregningen er baseret på tal for medicinpriser og tilskud i 2023.
Med et BMI over 30 anses man for at være svært overvægtig, mens et BMI i intervallet 18,5-24,9 anses for at være normalt.
.\˙ MarketWire
Negativ journalistik. - Man bør huske at glæde sig over, at et nyt medikament betyder, at nogle mennesker kan få det bedre.
Ikke udelukkende. Med de tal som nævnes (og som er realistiske), vil de samlede sundhedsudgifter stige med 10%. Eller 1% af BNP....
Der er og bliver en selvbetaler...
Der er og bliver en selvbetaler...
