FDA Grants Priority Review For Shire’s Velaglucerase Alfa

FDA has granted Priority Review for the New Drug Application (NDA) for velaglucerase alfa, Shire’s enzyme replacement therapy in development for the treatment of type 1 Gaucher disease.

Velaglucerase alfa is made using Shire’s proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and has a human glycosylation pattern.

In the US, patients continue to be enrolled in an FDA-approved treatment protocol, under which Gaucher patients receive velaglucerase alfa prior to commercialisation.

The company said that it is also engaged with national and regional authorities outside the US and patients are receiving velaglucerase alfa through pre-approval access programs. Shire confirms it is on track with its filing of the Marketing Authorisation Application (MAA) in the EU for 2009.