Cardiovascular

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

The company posted positive initial results from the Heart-2 trial in HeFH and CAD, with strong LDL cholesterol lowering and a clean safety profile.

Merck & Co., which already has an oral PCSK9 inhibitor in Phase III, licensed Hengrui’s Lipoprotein(a)-lowering small molecule HRS-5346 outside of Greater China for $200m up front.

Bristol Myers Squibb has been in a rapid growth phase to make up for upcoming losses of exclusivity. Scrip spoke with executives about further catalysts coming in the next 18-24 months.

Amgen saw revenue rise 19% to $33.4bn in 2024 and said revenue should grow to $34.3bn-$35.7bn in 2025 despite losing exclusivity for its biggest franchise – Prolia and Xgeva (denosumab) – this year.

Lilly’s revenue is rising rapidly based on its successes in diabetes and obesity, and the company is reinvesting in big plays in those markets as well as in cancer, lipid-lowering and other indications.

Repatha was not an overnight success, but the work Amgen has done to turn its PCSK9 inhibitor into a blockbuster is informing its strategy for Lp(a)-reducing olpasiran and obesity drug MariTide.

In Vivo speaks with Ashley Zehnder, CEO of Fauna Bio, a company using AI to identify drug targets based on natural disease resistance in animals.

Semaglutide 7.2mg bests placebo for weight loss at 72 weeks, but with efficacy lower than seen with Novo Nordisk’s CagriSema or Lilly’s Zepbound.