Genzyme's Lumizyme delayed by FDA complete response and warning letters
This article was originally published in Scrip
Executive Summary
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.