Posted by Michael Wonder on 17 Oct 2022
Mereo BioPharma receives FDA fast track designation for alvelestat for treatment of alpha-1 antitrypsin deficiency-associated lung disease
17 October 2022 - Mereo BioPharma today announced that the US FDA has granted fast track designation for its investigational oral neutrophil elastase inhibitor, alvelestat (MPH-966).
Mereo intends to have an end of Phase 2 meeting with the FDA to discuss the design of a registration enabling study for alvelestat as a treatment for AATD-associated lung disease, including the potential opportunity for an accelerated approval pathway, around the end of the year.
