Shire to file license application for Replagal

Shire has revealed that it plans to file a biologics license application for its enzyme replacement therapy for Fabry disease Replagal (agalsidase alfa).

The submission will be made before the end of 2009, Shire added, as it also announced that a treatment protocol for Replagal ? which was filed at the request of the Food and Drug Administration – has been approved.

Sylvie Gregoire, president of Shire’s human genetic therapies department, said that the company is eager to offer Fabry patients the chance to access Replagal.

“There is an abundance of long-term experience with Replagal in Fabry sufferers since the product has been commercially available outside of the United States since 2001,” Ms Gregoire added.

Last week, Shire announced that it settled all pending litigation with Sandoz in connection with the latter firm’s abbreviated new drug application and its attempt to market generic versions of Shire’s Adderall XR (mixed amphetamine salts).