Genzyme Corp. has received from the US Food and Drug Administration an extension by 90 days to review the biologics license application (BLA) for Myozyme (alglucosidase alfa). The new action date for the application is April 28, 2006. The purpose of the extension is to provide the FDA with sufficient time to review additional information submitted by Genzyme in late December at the agency's request.
"This is a brief extension of the review period, and we continue to expect that Myozyme will be approved in the United States during the first half of this year. We have worked closely with the FDA throughout the review process and are confident the agency recognizes the urgency of making this treatment available to patients," said Alison Lawton, Genzyme's senior vice president for regulatory affairs.
Myozyme has been developed for the treatment of Pompe disease, a debilitating, progressive and often fatal muscular disorder. Genzyme submitted a biologics license application for Myozyme in late July. The application was given priority review status, which required the FDA to act within six months, states the company release.
Genzyme is currently engaged in a broad range of activities to prepare for Myozyme's introduction in the United States and in Europe, where the Committee for Human Medicinal Products (CHMP) is expected to issue an opinion later this month on the marketing authorisation application for Myozyme.
Approximately 200 patients in 14 countries are currently receiving Myozyme through clinical trials, expanded access programmes, or pre-approval regulatory mechanisms.