US FDA accepts Genzyme's resubmission of Lumizyme
This article was originally published in Scrip
The US FDA has accepted Genzyme's resubmission of the BLA for its injectable Pompe disease treatment Lumizyme (alglucosidase alfa) seeking approval for the therapy produced at a 4000 litre scale, and has designated it as a class 2 response, which carries a six month review timeline. The user-fee date is on June 17th.
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