US FDA declines to approve Abeona's skin disorder treatment (updated)

Abeona Therapeutics

22/04/2024 21:27

(Adds details)
       April 22 (Reuters) - Abeona Therapeutics  ABEO.O  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)
 ((Pratik.Jain@thomsonreuters.com;))