FDA accepts velmanase alfa BLA for priority review

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) filing from Chiesi Global Rare Diseases, and granted priority review designation for velmanase alfa, an investigational enzyme replacement therapy for the treatment of alpha-mannosidosis.

The FDA set a Prescription Drug User Fee Act (PDUFA) date in the first half of 2023.

"People who are living with rare diseases can count on our long-term commitment to research and innovation as evidenced by the progress we have made in advancing our development program in alpha-mannosidosis to a BLA filing," said Giacomo Chiesi, head of Chiesi Global Rare Diseases, a US subsidiary of family controlled Italian drugmaker Chiesi Farmaceutici.