An FDA advisory committee voted in favor of approving Amgen’s (AMGN) cholesterol drug Repatha Wednesday afternoon, but voiced similar concerns as it did for Regeneron’s (REGN) and Sanofi’s (SNY) fellow PCSK9 inhibitor Tuesday. Still, Amgen stock was up about 1% in after-hours trading Wednesday after rising a fraction in the regular session. The panel voted 11-4 in favor of approving Repatha for patients with heterozygous familial
An FDA advisory committee voted 13 to 3 late Tuesday in favor of approving cholesterol buster Praluent, though lingering questions remained about just how many people it will treat. Praluent, from the team-up of Regeneron Pharmaceuticals (REGN) and Sanofi (SNY), is due for a final decision on approval by July 31. Analysts expect multibillion-dollar annual sales eventually. While this would be significant even for big pharma Sanofi, it’s so crucial
Speculation about the newest class of cholesterol drugs heated up Friday after the FDA released briefing documents for Tuesday’s advisory committee meeting on Praluent, the PCSK9 inhibitor from Regeneron Pharmaceuticals (REGN) and Sanofi (SNY). Nevertheless, Regeneron stock rose to an all-time high Friday for the second straight day. The documents framed the issues to ponder when the panel votes on whether to recommend approving the drug, advice