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: [[ticker: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.
Author: Luke Timmerman
Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.
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