The Committee for Medicinal Products for Human Use issued the positive opinion following a reexamination procedure, signaling a shift in the regulatory outlook for trofinetide. This therapy targets Rett syndrome, a complex disorder impacting roughly one in every 10,000 to 15,000 female births globally. The condition typically manifests through repetitive hand movements and gait abnormalities, leaving many patients in need of constant, round-the-clock care.

The European Commission now takes up the review process to finalize the authorization. While the timeline remains subject to regulatory deliberation, a formal decision is anticipated within the coming months. If approved, Daybu would provide a significant new pathway for managing a condition that currently lacks extensive therapeutic options.