abrooklyn
7 months ago
Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Source: PR Newswire (US)
Wegovy® (semaglutide) injection 2.4 mg is the first-and-only medicine indicated for both reduction of the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke and for long-term weight management1
The approval is based on the results of SELECT, the largest cardiovascular outcomes trial ever completed for people with obesity and known heart disease2
PLAINSBORO, N.J., March 8, 2024 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an additional indication for Wegovy® to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight along with a reduced calorie diet and increased physical activity.1 This new indication adds to the prescribing label for Wegovy®, a prescription-only medicine previously approved help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off when used along with a reduced calorie diet and increased physical activity.1
Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9253451-novo-nordisk-wegovy-semaglutide-fda-approval/
"Today, we're taking a pivotal step forward in addressing some of the most pressing health issues of our time with the added indication for Wegovy®," said Doug Langa, Executive Vice President, Head of North America Operations, and President of Novo Nordisk Inc. "We recognize how important this moment is for the millions of people who live with excess weight or obesity and known heart disease, and we will continue to advance options that put their needs first. Reducing this risk is a key part of our commitment to driving change for this community, as we work to increase manufacturing capacity to responsibly supply this important medicine."
The FDA decision is based on the results of the landmark SELECT phase 3 cardiovascular outcomes trial that examined the effect of adding Wegovy® 2.4 mg or placebo to cardiovascular standard of care in adults with overweight and obesity with established CVD and without diabetes.2 Wegovy® 2.4 mg significantly reduced the risk for first occurrence of a three-part composite MACE endpoint consisting of cardiovascular death, non-fatal heart attack, or non-fatal stroke.1,2 The primary composite outcome occurred in 6.5% of patients treated with Wegovy® and 8.0% with placebo. The estimated relative risk reduction of MACE was 20% vs placebo (HR 0.80 [95% CI: 0.72, 0.90] p
abrooklyn
1 year ago
Novo Nordisk Reports Surging Demand for Diabetes, Obesity Drugs Ozempic and Wegovy
Source: Dow Jones News
By Dominic Chopping
Danish pharmaceutical company Novo Nordisk on Thursday expanded its share buyback program by 2 billion Danish kroner ($297 million) as first-quarter earnings beat forecasts amid surging demand for its Ozempic diabetes drug and Wegovy obesity treatment.
Net profit in the quarter rose to DKK19.81 billion from DKK14.21 billion, beating the DKK19.12 billion forecast by analysts in a FactSet poll.
Sales rose 27% to DKK53.37 billion, versus the roughly DKK52.5 billion implied by recent company guidance.
The company last month pre-announced approximate first-quarter earnings figures and raised full-year guidance after noting strong sales trends for Wegovy. It also expects higher sales of Ozempic which was developed to treat diabetes but is being used "off label" by patients to treat obesity as it shares the same active ingredient as Wegovy--semaglutide.
Semaglutide is a glucagon-like peptide-1 drug, or GLP-1; a class of drugs that mimic a hormone to produce more insulin, lower blood glucose and slow stomach emptying after eating, helping to treat both Type 2 diabetes and obesity.
Ozempic sales rose 63% on the year to DKK19.64 billion, while Wegovy sales soared to DKK4.56 billion from DKK1.4 billion.
"Growth is driven by increasing demand for our GLP-1-based diabetes and obesity treatments, particularly in the U.S. where the prescription trend for Wegovy highlights the high unmet need for people living with obesity," Chief Executive Lars Fruergaard Jorgensen said.
The company still expects 2023 sales growth of 24%-30% and operating profit growth of 28%-34% on year in local currencies.
Write to Dominic Chopping at dominic.chopping@wsj.com
(END) Dow Jones Newswires
May 04, 2023 02:16 ET (06:16 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
Swe_bio_
7 years ago
Novo Nordic gets competition by the Danish company Saniona.
Can Saniona potentially be a threat to Novo Nordisk?
"I flæsket på Novo!
På Dansk Aktionærforenings InvestorDagen viste Saniona resultaterne fra tidligere studier med Tesofensine, der viste et vægttab efter 24 uger på 9,2% og på 14-15% efter 48 uger. Novos Victoza gav til sammenligning et vægttab på 6,0% efter 56 uger. Der er derfor begrundet formodning for, at studiet i Mexico vil kunne fremvise et tilstrækkeligt vægttab – resultater, der muligvis offentliggøres allerede næste år – og således en effekt, der er på niveau med Novos forhåbninger til Semaglutide, der i modsætning til Sanionas pille, skal gives som injektion."
Google translate to english
"At the Danish Shareholders' Association Investor Day, Saniona showed the results of previous studies with Tesofensine, showing a weight loss after 24 weeks of 9.2% and of 14-15% after 48 weeks. By comparison, Novos Victoza gave a weight loss of 6.0% after 56 weeks. There is, therefore, a reason to suspect that the study in Mexico will be able to show adequate weight loss results that may be published next year - and thus an effect that is in line with Novo's aspirations for Semaglutide, which, in contrast to Saniona's pill, should be given as an injection.
https://gallery.mailchimp.com/b37c4695f194050744e659a1a/files/ba3e9be4-214c-4e8f-bf65-b7c14e97fcad/Saniona_2017_09_21.pdf"
Alpha Deal Group Analysis - Saniona
https://www.biostock.se/wp-content/uploads/2017/07/Saniona_AB_24072017_24.pdf
https://www.biostock.se/wp-content/uploads/2017/07/Saniona_AB_24072017_24.pdf
TREND1
7 years ago
Novo Nordisk’s new fast-acting mealtime insulin Fiasp® approved in the US
Bagsværd, Denmark, 29 September 2017 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Fiasp ® (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes. The FDA’s decision comes after Fiasp ® in clinical trials demonstrated benefits for people in need of improved overall glucose control.
Fiasp ® is an innovative formulation of insulin aspart (NovoLog ® ) developed with the aim of obtaining pharmacokinetic and pharmacodynamic properties that more closely match the natural physiological insulin mealtime response of a person without diabetes.
In clinical trials Fiasp ® has demonstrated clinically relevant improvement in long-term glucose level (HbA 1c ). These results were achieved with a comparable overall rate of severe or blood-sugar confirmed hypoglycaemia, between Fiasp ® and insulin aspart.
“We are very pleased that Fiasp ® will now also be available to people with diabetes in the US,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The fast action profile of Fiasp ® allows people with diabetes convenient timing in terms of when to take their insulin in connection with meals to achieve the optimal blood sugar control.”
About Fiasp ®
Fiasp ® is insulin aspart in an innovative formulation, in which two excipients have been added: Vitamin B3 (niacinamide) to increase the speed of absorption and a naturally occurring amino acid (L-Arginine) for stability. The review of Fiasp ® was based on the ‘onset’ programme, a phase 3 clinical programme comprising four trials encompassing more than 2,100 people with type 1 and type 2 diabetes.
north40000
8 years ago
I wonder whether NVO, Sanofi or LLY is establishing a position here:
LXRX: http://www.prnewswire.com/news-releases/lexicon-reports-positive-top-line-results-in-pivotal-phase-3-study-for-sotagliflozin-in-patients-with-type-1-diabetes-300325393.html
"...THE WOODLANDS, Texas, Sept. 9, 2016 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that the pivotal inTandem1 Phase 3 clinical trial of sotagliflozin met its primary endpoint, showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin.
Top-line results from the Phase 3 study showed that patients treated with sotagliflozin had a mean A1C reduction from baseline of 0.43% on 200mg once daily sotagliflozin dose (p<0.001) and a reduction of 0.49% on 400mg once daily sotagliflozin dose (p<0.001) as compared to a reduction of 0.08% on placebo after 24 weeks of treatment, meeting the study's primary endpoint. This statistically significant and clinically meaningful improvement in A1C for both doses of sotagliflozin was achieved without an increase in severe hypoglycemia, one of the most prevalent serious health challenges in type 1 diabetes, which was seen less frequently in both treatment arms than placebo.
"We are extremely pleased with these top-line results and the potential long-term benefits that sotagliflozin may bring to people with type 1 diabetes," said Lexicon President and Chief Executive Officer Lonnel Coats. "We believe these results provide evidence that sotagliflozin, with its novel dual inhibition of both SGLT-1 and SGLT-2, is particularly well suited to help these individuals achieve better A1C levels without increasing and possibly reducing the risk of severe hypoglycemia."
"Our companies are working together to develop this compound for the treatment of type 1 and type 2 diabetes," said Jorge Insuasty, Senior Vice President, Head of Global Development, Sanofi. "These top-line results highlight potential benefits of sotagliflozin when treating adults with type 1 diabetes. We congratulate our partners on this positive outcome and look forward to further exploring this compound for the treatment of adults with type 2 diabetes when Sanofi begins the Phase 3 program later this year." [More]
It added to a position in CLCD recently....active in migraine field....
CLCD’s largest shareholder, NVO, bought $2M of stock in CLCD’s 9/9/16 public offering:
https://www.sec.gov/Archives/edgar/data/1348649/000120919116141046/xslF345X03/doc4.xml
NVO has close to a 20% stake in CLCD.
TREND1
9 years ago
Novo Nordisk to initiate phase 3a development of oral semaglutide, a once-daily oral GLP-1 analogue
Bagsværd, Denmark, 26 August 2015 - Novo Nordisk today announced the decision to initiate a phase 3a programme with oral semaglutide; a once-daily oral formulation of the long-acting GLP-1 analogue semaglutide. The decision follows the encouraging results of the proof–of-concept phase 2 trial announced on 20 February 2015 and the subsequent consultations with regulatory authorities.
Novo Nordisk intends to initiate a global phase 3a programme, named PIONEER, comprising seven trials with approximately 8,000 people with type 2 diabetes. The PIONEER programme will include six safety and efficacy trials and one trial for evaluating the cardio-vascular safety of oral semaglutide. The first trial in the programme is planned for initiation in first quarter of 2016 and will investigate the efficacy and safety of once- daily oral semaglutide doses of 3 mg, 7 mg and 14 mg, compared to once-daily oral anti- diabetic sitagliptin dose of 100 mg. The remaining six trials of the PIONEER programme are all expected to be initiated during 2016.
In order to meet capacity requirements for current and future diabetes care products, including oral semaglutide, Novo Nordisk expects to invest an estimated 2 billion US dollars over the coming five years in two new production facilities; a new production facility for a range of active pharmaceutical ingredients in Clayton, North Carolina, US and a new drug-product facility in Måløv, Denmark. The final design and cost of the new production facilities will be presented for approval by the company’s board of directors in 2016.
“Delivering protein-based medicine like semaglutide in the form of a tablet and producing it on a large scale is a major challenge, and with the announcement today we have reached a significant milestone towards achieving that goal”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We are excited about the opportunities oral semaglutide represents as a new oral anti-diabetic agent to further improve type 2 diabetes treatment”.
Page 2 of 2
About semaglutide
Semaglutide (NN9924) is a new glucagon-like peptide-1 (GLP-1) analogue that can help people with type 2 diabetes achieve substantial lowering of blood glucose with a low risk of hypoglycaemia. In addition, semaglutide induces weight loss by decreasing appetite and food intake. The oral formulation of semaglutide is provided in a tablet formulation with SNAC, an absorption-enhancing excipient included in the Eligen® Carrier Concept. The Eligen® technology is licenced from Emisphere Technologies, Inc.
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further information
Media:
Katrine Sperling +45 3079 6718 krsp@novonordisk.com
Ken Inchausti (US) +1 609 514 8316 kiau@novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Daniel Bohsen +45 3079 6376 dabo@novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz@novonordisk.com
Frank Daniel Mersebach (US) +1 609 235 8567 fdni@novonordisk.com
Novo Nordisk A/S
Investor Relations
Novo Allé
2880 Bagsværd
Denmark
Telephone:
+45 4444 8888
Internet:
www.novonordisk.com
CVR no:
24 25 67 90
Company announcement No 52 / 2015
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: August 26, 2015
NOVO NORDISK A/S
Lars Rebien Sørensen,
Chief Executive Officer
Novo Nordisk A S (NYSE:NVO)
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More NVO MessagesLatest Novo-Nordisk A/S, NVO Messages
NVO PF
TREND1 • Wed Aug 26, 2015 2:06 PM (7 minutes ago)
Inst % Owned = 7%
TREND1 • Wed Aug 26, 2015 2:05 PM (8 minutes ago)
EPS= 10.10
TREND1 • Wed Aug 26, 2015 2:04 PM (9 minutes ago)
NVO D
TREND1 • Wed Aug 26, 2015 2:03 PM (10 minutes ago)
NVO D
TREND1 • Tue Nov 4, 2014 4:33 PM
FROM DEW
TREND1 • Thu Oct 30, 2014 11:25 AM
THANKS
TREND1 • Tue Oct 28, 2014 1:36 PM
Yes—see #msg-107612584.
DewDiligence • Tue Oct 28, 2014 1:02 PM
Was NOV drop due to reaction of SNY
TREND1 • Tue Oct 28, 2014 12:01 PM
NVO D
TREND1 • Sat Oct 25, 2014 3:04 PM
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TREND1
10 years ago
Eli Lilly & Co.'s Type 2 diabetes drug Trulicity has been approved by the U.S. Food and Drug Administration, the agency said Thursday. The drug is a subcutaneous injection that helps improve blood-sugar levels. Lilly plans to launch Trulicity 0.75 mg and 1.5 mg single-dose pens later this year, the company said Thursday. This is the first regulatory approval for the drug, which has been submitted to other regulators including the European Medicines Agency and other regulatory bodies. The FDA is requiring certain post-marketing studies for Trulicity, including a clinical trial to evaluate effectiveness and safety in pediatric patients. After the company met with analysts to discuss the drug in June, J.P. Morgan estimated Trulicity would post about $1.4 billion in 2020 sales. Trulicity, or dulaglutide, belongs to a class of drugs called GLP-1 receptor agonists, which work by stimulating the body's natural production of insulin and help regulate blood-sugar levels. Lilly said in February that the drug was comparable to Novo Nordisk A/S's (NVO) once-daily Victoza in reducing a measure of blood sugar in a patient study.
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