At least seven PDUFA dates on deck in November

Among the seven FDA approval decisions expected this month are Apellis’ intravitreal pegcetacoplan, the most advanced of a large pipeline of complement inhibitors aiming to treat geographic atrophy, and Provention’s teplizumab, which could become the first approved therapy to delay the onset of Type I diabetes.

The crowded complement inhibitor field will be watching closely FDA’s decision, due Nov. 26, on C3 inhibitor pegcetacoplan from  Apellis Pharmaceuticals Inc. (NASDAQ:APLS). The therapy is one of six complement inhibitors in development for the indication, with the next in line, Zimura avacincaptad pegol from Iveric bio Inc. (NASDAQ:ISEE), also targeting C3. The two have shown a similar slowing of extrafoveal lesion growth in Phase III trials. Iveric is aiming for a 1Q23 NDA submission. ...