NVO Gets Positive CHMP Opinion in EU for Ozempic Expanded Use in CKD

Novo Nordisk NVO announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the label expansion of Ozempic (semaglutide) to treat patients with type II diabetes (T2D) and chronic kidney disease (CKD) in the EU. Subject to approval, the drug will be indicated as an adjunct to the standard of care for the prevention of the progression of renal impairment in T2D and CKD patients. A final decision from EMA is expected soon.Please note that Novo Nordisk’s once-weekly subcutaneous diabetes injection, Ozempic, is already approved in 0.25 mg, 0.5 mg, 1 mg and 2 mg doses for treating T2D mellitus in adults, adjunct to diet and exercise. Ozempic is also approved for reducing the risk of major adverse cardiovascular events in adults with T2D mellitus and established cardiovascular disease.The recommendation from the CHMP was based on positive results from Novo Nordisk’s FLOW outcomes study, which achieved its primary endpoint of a superior reduction of 24% in kidney disease progression, as well as cardiovascular and kidney death for people treated with semaglutide 1 mg against placebo, with statistical significance.In the past three months, shares of NVO have plunged 20.7% compared with the industry’s 14.7% decline.Image Source: Zacks Investment ResearchThe composite primary endpoint of the study included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality. Novo Nordisk claimed that both CKD and cardiovascular components of the primary endpoint contributed to the risk reduction.Additionally, the FLOW study also met its key confirmatory secondary endpoints, demonstrating an 18% reduction in the risk of major cardiovascular events and a 20% reduction in the risk of all-cause mortality.Per Novo Nordisk, approximately 40% of T2D patients develop CKD, which represents a huge unmet need for treatments that can help reduce kidney disease progression. Following the positive opinion in the EU, Ozempic is on track to become the first and only GLP-1 receptor agonist to show a lowering of risk of kidney disease progression in adults with T2D and CKD.A similar filing in the United States seeking the label expansion of Ozempic in the United States for treating patients with T2D and CKD is also currently under review. A decision from the regulatory body is expected in the first half of 2025.Semaglutide - NVO’s Growth EnginePlease note that Novo Nordisk also markets semaglutide (GLP-1 agonist) under the brand names, Rybelsus oral tablet for T2D and Wegovy injection for chronic weight management. The company enjoys around 54% value market share in the GLP-1 segment, primarily on the back of its semaglutide medicines.Wegovy is a significant contributor to Novo Nordisk's revenues. Despite supply challenges limiting the company’s ability to meet investor sales expectations, Wegovy continues to show strong prescription growth, driving higher revenues and profits. The company is making substantial investments to expand production capacity to address rising demand.Wegovy’s label was expanded in the United States in March 2024 to reduce the risk of serious heart problems in obese/overweight adults, which has been boosting its sales. The drug’s label was also recently expanded in the EU for the same indication. The company is also looking to expand the drug’s label to treat patients with obesity-related heart failure with preserved ejection fraction in the EU and U.S. markets. Additionally, a late-stage cardiovascular outcomes study, evaluating Rybelsus as an adjunct to the standard of care for the prevention of serious heart problems in T2D patients, recently met its primary endpoint.The company is also studying semaglutide for metabolic dysfunction-associated steatohepatitis (MASH). Last month, Novo Nordisk reported positive results from part 1 of its pivotal phase III ESSENCE study in 1,200 adults with MASH and moderate to advanced liver fibrosis. Per the data readout, the study achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo.NVO is currently gearing up to file for regulatory approvals of semaglutide 2.4 mg to treat MASH in the United States and EU in the first half of 2025. Results from part 2 of the ESSENCE study are expected in 2029.Novo Nordisk A/S Price and Consensus Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S QuoteNVO’s Zacks Rank and Stocks to ConsiderNovo Nordisk currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX, and Spero Therapeutics SPRO, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.In the past 60 days, 2024 estimates for Castle Biosciences have improved from a loss of 58 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.84. In the past three months, shares of Castle Biosciences have lost 5.9%.CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. In the past three months, CTMX stock has lost 7.4%%.CytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. In the past three months, Spero’s shares have lost 19.7%.SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.Free Report: 5 Clean Energy Stocks with Massive UpsideEnergy is the backbone of our economy. It’s a multi-trillion dollar industry that has created some of the world’s largest and most profitable companies.Now state-of-the-art technology is paving the way for clean energy sources to overtake “old-fashioned” fossil fuels. Trillions of dollars are already pouring into clean energy initiatives, from solar power to hydrogen fuel cells.Emerging leaders from this space could be some of the most exciting stocks in your portfolio.Download Nuclear to Solar: 5 Stocks Powering the Future to see Zacks’ top picks free today.Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novo Nordisk A/S (NVO): Free Stock Analysis Report CytomX Therapeutics, Inc. (CTMX): Free Stock Analysis Report Spero Therapeutics, Inc. (SPRO): Free Stock Analysis Report Castle Biosciences, Inc. (CSTL): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks