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
Big biotech Regeneron Pharmaceuticals (REGN) was down nearly 5% Wednesday as Wall Street digested the impact of an ambiguous FDA advisory committee vote on its cholesterol drug Praluent late Tuesday. Meanwhile, rival Amgen (AMGN) was off 2% as the committee reconvened to vote on its similar drug Repatha. The panel endorsed approval overall, but the caution around the real connection between lower LDL cholesterol and cardiovascular health raised
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