Replagal Advisory Committee Will Include Closed Door Session On Manufacturing
This article was originally published in The Pink Sheet Daily
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.
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Distributed free of charge to U.S. patients with Genzyme’s Fabrazyme in short supply, Replagal seemed destined for quick approval, but FDA has signalled otherwise.
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.
Human Genetic Therapies division President Gregoire also says self-administration should be a key point of differentiation for Firazyr in the HAE market.