US FDA declines to approve Abeona’s skin disorder treatment

By Thomson Reuters Apr 22, 2024 | 3:31 PM

(Reuters) – Abeona Therapeutics said on Monday the U.S. health regulator had declined to approve its treatment for a rare skin blistering condition.

In its so-called “Complete Response Letter”, the Food and Drug Administration requested certain additional information to satisfy a critical part of any pharmaceutical product application.

The drug developer is seeking approval for the treatment in patients with recessive dystrophic epidermolysis bullosa, where the skin becomes fragile and blisters can appear through rubbing or exposure to heat.

(Reporting by Pratik Jain in Bengaluru; Editing by Sriraj Kalluvila)