Sanofi: FDA priority review for Pompe disease drug
(CercleFinance.com) - Sanofi has announced that the US FDA has given priority review to the application for a biological product licence for avalglucosidase alfa, for long-term enzyme substitute treatment of patients with Pompe disease.
This rare degenerative muscle disease can adversely affect a person's ability to move and breathe. About 3,500 people suffer from this disease in the US according to estimates - of any age. The FDA is expected to make its decision on 18 May 2021.
In October, the European Medicines Agency agreed to examine the application for marketing authorisation. The Medicines and Healthcare Products Regulatory Agency in the UK has granted Promising Innovative Medicine designation for avalglucosidase alfa.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
This rare degenerative muscle disease can adversely affect a person's ability to move and breathe. About 3,500 people suffer from this disease in the US according to estimates - of any age. The FDA is expected to make its decision on 18 May 2021.
In October, the European Medicines Agency agreed to examine the application for marketing authorisation. The Medicines and Healthcare Products Regulatory Agency in the UK has granted Promising Innovative Medicine designation for avalglucosidase alfa.
Copyright (c) 2020 CercleFinance.com. All rights reserved.