Shire Completes Submission Of NDA For Velaglucerase Alfa

Shire has completed its submission of a New Drug Application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the FDA.

The company has also announced positive results from the final two phase III studies of velaglucerase alfa, with both studies reaching all of their primary and secondary endpoints.

All three phase III studies of velaglucerase alfa demonstrated positive results. The product was generally well-tolerated in both treatment naive and previously treated Gaucher patients.

Reportedly, the three studies included; Study 032, which studied velaglucerase alfa in naive patients; Study 039, which was a head-to-head study of velaglucerase alfa and imiglucerase; and Study 034, which was a switch study from imiglucerase to velaglucerase alfa.

Sylvie Gregoire, president of Shire Human Genetic Therapies, said: “The submission of the NDA for velaglucerase alfa, earlier than previously announced, is an important milestone for Shire, bringing us another step closer to providing a new treatment option for patients with Type 1 Gaucher disease.

“We are also pleased to report that the data from our final two phase III trials met our expectations by reaching all of their primary and secondary endpoints, demonstrating consistency with the results recently reported from the first phase III trial. In addition, we are on-track to submit our European filing for velaglucerase alfa by the end of 2009.”