- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- FDA advisory panel to consider OTC status of NSAIDs
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- Reports: ESI may start 'price war' over new hepatitis C drugs
- Diplomat becomes distributor of recently approved cancer drug
CAMBRIDGE, Mass. — A Sanofi company is seeking regulatory approval from the Food and Drug Administration for a drug designed to treat relapsing multiple sclerosis.
Genzyme said it submitted a supplements biologics license application to the FDA for Lemtrada (alemtuzumab), which the drug maker is developing in collaboration with Bayer HealthCare Pharmaceuticals. Genzyme's clinical development program for the Lemtrada included two phase-3 studies in which results for Lemtrada were superior to Rebif (high dose subcutaneous interferon beta-1a) on clinical and imaging endpoints, including a reduction in relapse rate.
"There remains a large unmet treatment need for patients living with active disease and we believe that Lemtrada, given its efficacy and unique dosing schedule, has the potential to transform the lives of patients with MS," Genzyme president and CEO, David Meeker said.