Shire to Seek FDA Approval for Replagal This Year

Shire is planning to file a BLA for its Fabry disease treatment Replagal by the end of the year to supplement the short supply of such drugs caused by a Genzyme manufacturing issue. Shire has filed a treatment protocol for Replagal (agalsidase alfa) at the request of the FDA, and it will support emergency IND requests, the company says in a statement.
Drug Industry Daily