Posted by Michael Wonder on 31 Oct 2024
Abeona Therapeutics completes Pz-cel biologics license application resubmission to US FDA
29 October 2024 - Abeona Therapeutics today announced that the Company has resubmitted its biologics license application to the US FDA for prademagene zamikeracel, its investigational autologous cell-based gene therapy, as a potential new treatment for patients with recessive dystrophic epidermolysis bullosa.
The biologics license application resubmission is supported by clinical efficacy and safety data from the pivotal Phase 3 VIITAL study (NCT04227106) and a Phase 1/2a study (NCT01263379).
