Novo Nordisk A/S NVO announced that the European Commission has granted marketing authorization to Rybelsus (oral semaglutide) for the treatment of adults with insufficiently-controlled type 2 diabetes to improve glycemic control as an adjunct to diet and exercise.
Rybelsus is expected to be launched in the second half of 2020 across all 27 European Union member states and the United Kingdom.
The approval in Europe was based on data from 10 PIONEER clinical studies on Rybelsus. Per the company, following 52 weeks of treatment, Rybelsus demonstrated statistically significant reductions in HbA1c vs sitagliptin, empagliflozin and liraglutide and with up to 4.3 kg weight decline. The drug showed a safe and well-tolerated profile across the PIONEER program.
In January 2020, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion, recommending marketing authorization for Rybelsus regarding the above-mentioned indication.
Shares of Novo Nordisk have increased 3.4% so far this year against the industry’s decline of 10.5%.
Notably, in September 2019, the FDA approved semaglutide in tablet form, marketed under the brand name Rybelsus. It won the nod as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus.
Rybelsus is the first-approved glucagon-like peptide-1 (GLP-1) receptor agonist in a tablet form across the United States, Switzerland and in EU.
The drug is also under review by several regulatory bodies including the Japanese Pharmaceuticals and Medical Devices Agency.
We remind investors that semaglutide is approved in the United States as a once-daily pre-filled pen to improve glycemic control in type II diabetes patients. It is also approved across Europe, Japan and Canada for the same indication and marketed under the brand name Ozempic.
In January 2020, the FDA nodded to a label expansion of once-weekly injection Ozempic for lowering the risk of cardiovascular events. The FDA approved the supplemental new drug application (sNDA) for Ozempic for reducing the risk of major adverse cardiovascular (CV) events (MACE) including cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with type II diabetes and established cardiovascular disease (CVD).
We note that Novo Nordisk has a strong presence in the Diabetes care market. The company has one of the broadest diabetes portfolios in the industry. Last July, Novo Nordisk and Gilead Sciences GILD initiated a phase II proof-of-concept study combining semaglutide of the former with the latter’s cilofexor (FXR agonist) and firsocostat (ACC inhibitor) to treat patients with nonalcoholic steatohepatitis (NASH).
Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large cap pharma sector include Eli Lilly and Company LLY and AbbVie Inc. ABBV. While Eli Lilly sports a Zacks Rank #1 (Strong Buy), AbbVie has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Eli Lilly’s earnings estimates have moved 0.1% north for 2020 and 0.1% north for 2021 over the past 60 days. The stock has rallied 6.3% year to date.
AbbVie’s earnings estimates have been revised 1.9% upward for 2020 and 0.9% upward for 2021 over the past 60 days.
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