FDA at last approves Genzyme's Lemtrada

The US Food and Drug Administration on Friday approved French pharma major Sanofi (Euronext: SAN) subsidiary Genzyme’s Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS), finally gaining access to the all important USA, which accounts for around 60% of the global MS market.

Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS, the FDA said. Use of Lemtrada as an MS treatment was a key factor in Sanofi’s 2011 $20.1 billion acquisition of Genzyme, and adds to Sanofi’s other MS drug, Aubagio (teriflunomide), which has already been cleared in the USA.

Germany’s Bayer (BAYN: DE) holds an option for co-promotion rights on alemtuzumab for MS in the USA. Alemtuzumab was previously approved under the Campath trade name for the treatment of leukemia, but that product has now been discontinued. Genzyme has said that it believes Lemtrada in the MS setting could generate annual revenues of $3.5 billion.