Lemtrada regulatory update

FDA refused to file an sBLA from Sanofi's Genzyme Corp. subsidiary for Lemtrada alemtuzumab to treat multiple sclerosis. According to Genzyme, the agency asked the company to "modify the presentation of the data sets to enable the agency to better navigate the application." The agency did not request additional data. Genzyme said it plans to resubmit the application "as soon as possible." An MAA for Lemtrada is under review in Europe. Genzyme declined to provide details.

Last year, Sanofi acquired Genzyme for about $20.1 billion, plus a $14 contingent value right (CVR), $13 of which is devoted to milestones for Lemtrada in MS (see BioCentury, Feb. 21, 2011 & April 11, 2011). In August, Genzyme said it withdrew cancer drug MabCampath alemtuzumab from the European market to prepare for commercialization of the drug under a different name and dosing regimen for MS. The unit said the U.S. version of the cancer drug, known as Campath, will no longer be available effective Sept. 4. MabCampath/Campath was marketed for B cell chronic lymphocytic leukemia (CLL) (see BioCentury, Aug. 27). ...