Shire Withdraws Replagal BLA Rather Than Conduct Lengthy Trials – Updated
This article was originally published in Pharmaceutical Approvals Monthly
Replagal seemed destined for quick approval – the enzyme replacement therapy was already distributed free of charge to U.S. patients in response to short supples of Genzyme’s Fabrazyme. But FDA has signaled otherwise, and Shire doesn’t think Replagal warrants the effort.
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FDA’s Cardiovascular and Renal Drugs Advisory Committee will assess Shire biologics’ BLA for the Fabry disease therapy, which already is available in the U.S. due to shortages of competitor Fabrazyme, during a March 27 meeting.
The subsidiary of Sanofi long has pegged opening of additional plant as critical to restoring full production of Fabrazyme, which has been rationed to Fabry disease patients since a manufacturing interruption in 2009.
Plagued by a virus, the biotech hopes to have Allston Landing facility back in operation by late July, but warns of short-term drug shortages.