The FDA has told beleaguered Genzyme that a new decision on Lumizyme, the company's drug for Pompe disease, will come in June--more than six months after the agency rejected the product for the second time.
The agency rejected the drug last March and then again in November. The second rejection was related to problems with the Allston-based manufacturing plant that produced it. Because of the production problems, Genzyme shifted production of the drug to a Belgium plant, Dow Jones reports. The drug is currently approved in 40 other countries, where it's called Myozyme.
However, Genzyme has promised it would address the FDA's concerns about the manufacturing processes at the Allston plant by adding internal controls and updating the filling and finishing capabilities. Genzyme also has entered an agreement with Illinois' Hospira to provide fill and finish manufacturing services.
Last week, Genzyme published its preliminary financial results for the final quarter of 2009, revealing revenues of $1.08 billion for the period, Zenopa reports.
- check out the company's announcement
- read Mass High Tech's coverage
- here's Dow Jones' report
- read more at Zenopa