AstraZeneca’s Epanova: Third In Omega-3 Market, Potentially First With Larger Population Claim
This article was originally published in The Pink Sheet Daily
Fish oil treatment is the first to offer a dosing regimen of as few as two capsules, once a day, with our without food, AstraZeneca said.
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Amarin signed Kowa Pharmaceuticals America as a commercial partner for its fish oil pill, more than doubling the number of sales reps detailing the medicine. Forma signed a second drug discovery pact with Celgene, while Baxter bolstered its hemophilia franchise by buying out partner Chatham Therapeutics.
AstraZeneca’s two-pronged approach to get its experimental fish oil-based heart drug Epanova approved by U.S. regulators is on track according to CEO Pascal Soriot. But an FDA Advisory Committee’s negative recommendation for Amarin’s similar drug, Vascepa, likely means the second step, seeking a label expansion for Epanova in a broader, less seriously ill population, will have to await full outcomes data.
Decreasing cardiovascular events is the only endpoint that matters for cholesterol-lowering drugs, FDA official says at Amarin’s negative Vascepa panel, leaving little room for drug’s expanded approval based on a surrogate endpoint.