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Home Industry News Shire Pharmaceuticals Group given FDA fast track designation for velaglucerase alfa

Shire Pharmaceuticals Group given FDA fast track designation for velaglucerase alfa

16th July 2009

Shire Pharmaceuticals Group’s enzyme replacement therapy velaglucerase alfa, which is currently in development for the management of type one Gaucher disease, has been given fast track designation by the Food and Drug Administration (FDA).

In a statement, the biopharmaceutical company explained that fast track designation is a process that speeds up the review of drugs that have the potential to treat serious conditions for which there are no treatments as yet.

The goal of the designation is to provide patients with important new therapies sooner than they would normally be available.

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

The firm is now working with the FDA to decide on subsequent steps and the timing for the submission of its new drug application for the therapy.

Earlier this month, Shire announced that its vice-chairman Dr Jeffrey Leiden has been appointed as a non-executive director of Vertex Pharmaceuticals.

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