Shire Files Treatment Protocol For Gaucher Disease

Shire, at the request of the FDA, has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development, for the treatment of Gaucher Disease.

Velaglucerase alfa is made with Shire’s proprietary technology, in a human cell line, said the company.

If approved by the FDA, the treatment protocol would allow physicians to treat Gaucher Disease patients with velaglucerase alfa, ahead of commercial availability in the US. Under the conditions of the treatment protocol, Shire would provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible.

Shire is working with the FDA to file a New Drug Application for velaglucerase alfa as early as possible.