Genzyme's Lumizyme delayed by FDA complete response and warning letters

Genzyme received a double dose of bad news on February 27th when the US FDA issued complete response and warning letters delaying approval of Lumizyme, a version of the Pompe disease treatment Myozyme (alglucosidase alfa) produced at a larger manufacturing scale, by as much as six months.

Genzyme received a double dose of bad news on February 27th when the US FDA issued complete response and warning letters delaying approval of Lumizyme, a version of the Pompe disease treatment Myozyme (alglucosidase alfa) produced at a larger manufacturing scale, by as much as six months.

The company and agency failed to reach agreement before the February 28th user fee deadline on a post-marketing verification study, risk evaluation and mitigation strategy (REMS) and labelling, thus resulting...

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