Apellis Pharmaceuticals Inc., in collaboration with Sobi, announced that the marketing applications for EMPAVELI® (pegcetacoplan) are currently under review by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency $(EMA)$. This review pertains to the treatment's use in addressing rare kidney diseases, specifically C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The announcement follows the presentation of new data at the European Renal Association Congress, highlighting sustained efficacy and safety in a Phase 3 study. The companies are hopeful for an FDA decision by the upcoming summer, aiming to quickly make EMPAVELI available to patients with these severe conditions.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。