FDA to review oral MS drug Lemtrada

Genzyme Inc. said today the U.S. Food and Drug Administration has accepted for review the Cambridge-based company’s application seeking approval of Lemtrada to treat relapsing multiple sclerosis.

The company said it expects FDA action on the application in the second half of 2013. Genzyme added it has already submitted its marketing authorization application for Lemtrada to the European Medicines Agency and the review process is under way.

Treatment with Lemtrada, commonly known as alemtuzumab, results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in multiple sclerosis.

Genzyme also reported highlights from the U.S. launch of its once-daily oral medication Aubagio, which is also used to treat patients with relapsing forms of multiple sclerosis. The company said since its October launch, the drug has been prescribed by more than 80 percent of MS specialists.

Aubagio is approved for use in both the United States and Australia.

“The initial uptake of Aubagio by U.S. prescribers shows the importance of a once-daily oral option in MS,” said Genzyme President and CEO David Meeker. “In addition, the acceptance of the Lemtrada file in the U.S. marks another important milestone in bringing this potentially transformative therapy to MS patients. We look forward to a series of product launches in 2013 in Europe and other major markets.”

Source: Bostong Herald.com © Copyright 2013 by the Boston Herald and Herald Media (28/01/13)