PARIS Sanofi expects the U.S. Food and Drug Administration to rule on its application for multiple sclerosis treatment Lemtrada by the second half of this year.
The injectable drug, chemically known as alemtuzumab, is one of the new products the French drug maker is betting on to restore growth after losing several blockbusters to generic rivals.
The drug, which late-stage trials have shown helps people who have not responded to other multiple sclerosis treatments, has already been submitted for review by the European Medicines Agency.
In a statement, the French drugmaker also said that an expert committee at the EMA was expected to give its opinion on the medicine in the second quarter of 2013.
Sanofi's biotech subsidiary Genzyme developed Lemtrada, which was sold until September 2012 under the name Campath as treatment for leukemia and given more frequently at a higher dosage. Sanofi withdrew it from the market while it seeks to get it approved as a treatment for MS, although it remains available free of charge to leukemia patients.
Analysts said the move would allow the company to adjust the price to match that of rival MS drugs on the market.
(This story has been corrected to show that it is the European Medicines Agency that is due to give an opinion in the second quarter)
(Reporting by Leila Abboud; Editing Dominique Vidalon and Helen Massy-Beresford)