FDA agrees to give Ipsen's rare disease drug another look as palovarotene saga rumbles on

Despite an FDA rejection only three months ago, the saga of Ipsen’s rare disease candidate isn’t over yet—and there’s a chance it could still have a happy ending.

The biotech ended 2022 on a downer, with the FDA rejecting an application for palovarotene to treat an ultra-rare bone growth disorder called fibrodysplasia ossificans progressiva (FOP). The decision came two months after the agency delayed an advisory panel meeting to discuss palovarotene and requested additional data.