Apellis Pharmaceuticals, Inc. last week said the FDA has an updated a decision date for its closely watched eye drug pegcetacoplan: Feb. 26, 2023. A decision for the drug’s use in geographic atrophy, an advanced form of macular degeneration, was originally expected by the end of this month, but Apellis chose to submit expanded efficacy data to the agency, postponing the decision and giving some investors pause. There is currently no FDA-approved treatment for geographic atrophy on the market, which could make the C3 complement inhibitor a blockbuster. Pegcetacoplan has previously been approved for the treatment of paroxysmal nocturnal hemoglobinuria, a rare blood disease, under the brand name Empaveli. Empaveli currently holds covered or better status for 70% of all insured lives under the pharmacy benefit, and 47% under the medical benefit.
SOURCE: MMIT Analytics, as of 11/21/22