Category: Apellis Pharma

  • Longer-term data raise prospects for Apellis’ pegcetacoplan

    Apellis chances of getting regulatory approval for pegcetacoplan, its drug candidate for sight-robbing disease geographic atrophy (GA), may have been heightened by new follow-up data from two phase 3 trials. Before today’s readout, the score was one win and one loss for pegcetacoplan in the OAKS and DERBY trials respectively after 12 months’ treatment with […]

  • UCB preps filings for another challenger to AZ’s Soliris

    Belgian drugmaker UCB says it will be able to file not one but two new drug therapies for autoimmune disease generalised myasthenia gravis (gMG) this year, after its C5 inhibitor zilucoplan hit the mark in a phase 3 trial. Zilucoplan achieved a significant improvement in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score […]

  • EU gives narrower label to Apellis, Sobi’s PNH drug

    Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The European Commission has cleared the complement C3 inhibitor as Aspaveli for the treatment of adults with PNH who are anaemic, but only after they have been […]

  • Apellis reports mixed data with eye drug, but plans to file anyway

    Apellis Pharma’s has reported mixed results with its lead drug pegcetacoplan in geographic atrophy (GA) – a major cause of blindness – with one hit and one miss in its phase 3 programme. Shares in the company were hit hard after the news was announced, although Apellis insisted that the totality of the data would […]

  • Apellis set to take on Alexion as FDA clears PNH drug Empaveli

    Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly.  There had been speculation that the FDA might approve Empaveli (pegcetacoplan) only as a backup option for patients who don’t see […]