Shire Files for FDA Approval of Replagal

Shire Files for FDA Approval of Replagal

On Tuesday, Britain's giant drug manufacturer Shire PLC confirmed that it has filed an application with the US Food and Drug Administration for the American marketing approval of Replagal, the company's medicine to treat Fabry disease.

Currently, Replagal is available across the county under some specific restrictions, and the firm is seeking complete marketing approval now. Since 2001, the medicine has been on sale across Europe, as has been confirmed by Shire.

The medicine is used for the treatment of a rare disorder that is inherited, and is caused by the buildup of one specific type of fat in the body's cells.

Shire has now also shared that the FDA has already completed the pre-approval inspections of the firm's facilities across Cambridge and Lexington, Mass, and these inspection are a part of the agency's review of velaglucerase alfa, a medicine intended for the successful treatment of Gaucher disease.

In last recorded morning trading figures, shares of Shire slipped by 3 cents to $57.37.

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