Shire notes positive results from velaglucerase alfa phase III trial

Shire has reported positive results from the first of three phase III trials into velaglucerase alfa, the pharmaceutical company’s enzyme replacement therapy that is in development for the treatment of type 1 Gaucher disease.

In addition, the Food and Drug Administration (FDA) has accepted the company’s treatment protocol for velaglucerase alfa and Shire has initiated its rolling submission of the new drug application for the therapy under the Fast Track initiative.

Commenting, Sylvie Gregoire, president of Shire human genetic therapies, said that the company is “very pleased” with the progress of the research, from both regulatory and clinical perspectives.

“We will continue to work diligently with the FDA and other regulatory agencies to make velaglucerase alfa available as soon as possible to help meet the needs of the Gaucher community,” she added.

On July 16th, Shire announced that the FDA had authorised Fast Track designation for velaglucerase alfa, after the company filed a treatment protocol for the therapy earlier in the month.