Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDALEXINGTON, Massachusetts - - Treatment Protocol Accepted and Rolling Submission of New Drug Application Initiated Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher DiseaseLEXINGTON, Massachusetts - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease. Shire is working with the FDA to determine subsequent steps and timing for the filing of its NDA. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher DiseaseLEXINGTON, Massachusetts - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease. |
