Posted by Michael Wonder on 26 Sep 2023
Abeona Therapeutics submits biologics license application to US FDA seeking priority review and approval of EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa
26 September 2023 - Abeona Therapeutics today announced the Company has submitted a biologics license application to the US FDA seeking approval of EB-101, its investigational autologous, engineered cell therapy, as a treatment for patients with recessive dystrophic epidermolysis bullosa.
As part of the submission, Abeona requested a priority review, which, if granted, would shorten the FDA’s review period to six months from the filing acceptance of the biologics license application, instead of 10 months under standard review.
