January 28, 2013 |
Sanofi (NYSE: SNY ) announced today that the Food and Drug Administration accepted its supplemental Biologics License Application requesting permission to market Lemtrada for the treatment of relapsing multiple sclerosis.
The active ingredient in Lemtrada was originally approved as Campath to treat leukemia, but Sanofi pulled Campath off the market, with some speculating that this was because the difference between the leukemia dose and the multiple sclerosis dose would have made the drug extremely cheap for the multiple sclerosis patients.
The marketing application is based on two phase 3 studies comparing Lemtrada to Pfizer(NYSE: PFE ) and Merck KGaA's Rebif. One study compared the drugs in patients new to treatment while the other tested patients who had relapsed while on a prior therapy.
Sanofi expects a decision from the FDA in the second half of the year. A decision from the Committee for Medicinal Products for Human Use in the EU is expected in the second quarter
read more
..
If you would like, you can comment to our blog posts
LIKE this Blog by clicking the LIKE button - top left
REMAIN up to date with MS News and Education
Visit: www.msviewsandnews.org to register
.
1 comment:
heaven forbid you sell something to a ms patient that they can actually afford , and what are the side effects are they as bad as the disease itself.
Post a Comment