The all oral formulation -- as well as the efficacy data -- will make it a clear multi-blockbuster, for the company. Here's the Fierce take, as of about lunchtime on the East Coast:
. . .Merck has completed a hat trick of phase 3 victories for its oral PCSK9 inhibitor. Navigating into the broader hyperlipidemia population, the drugmaker stayed out of the shoals and charted a course to talks with regulators with another win for its CORALreef program.
The latest data come from a phase 3 trial that randomized adults with high cholesterol to receive the oral PCSK9 inhibitor enlicitide decanoate or placebo. Participants were taking stable lipid-lowering therapies, including a statin, and either had a history of a major atherosclerotic cardiovascular disease event or an increased risk for a first event. . . .
Amgen’s Repatha and Sanofi-Regeneron’s Praluent have long controlled the PCSK9 market. Those antibodies, as well as Novartis’ more recently approved siRNA drug Leqvio, are injected. The apparent lack of binding sites on the protein held back efforts to develop oral PCSK9 inhibitors. . . .
That's all I've got today -- as post vacation "power alley" junk. Onward.
नमस्ते
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