FDA Plans To Clear Genzyme’s Myozyme Made at Large Scale

Luke Timmerman11/17/08

Genzyme said today the FDA plans to allow it to market alglucosidase alfa (Myozyme) made in a large-scale 2000 liter bioreactor. The Cambridge, MA-based biotech company (NASDAQ: GENZ) said it first needs to agree with the agency on a risk-lowering strategy, and a post-marketing study that will look at whether the drug made at the larger scale is equivalent to the version currently approved for the market at a smaller scale. The FDA’s deadline to officially act has now been pushed back 90 days, to Feb. 28. Genzyme has said it expects to sell between $275 million and $285 million of the product this year, for a rare genetic condition called Pompe disease.

Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. E-mail him at ltimmerman@xconomy.com or follow him on Twitter at twitter.com/ldtimmerman.