Sanofi Takes Another Step Forward In MS, Files Lemtrada NDA
This article was originally published in The Pink Sheet Daily
Sanofi is seeking a six-month priority review for the multiple sclerosis drug Lemtrada, positioning it for a potential launch by the end of the year. Meanwhile, FDA action on Aubagio is expected in June.
You may also be interested in...
As Sanofi/Genzyme plans to take leukemia drug Campath out of the commercial market in the U.S. and Europe so it will not undercut sales of the same compound in a different indication, patient advocates are confident that a patient-access system will continue providing the drug to those who need it.
FDA user fee reauthorization eliminates limits on waivers, which may ease the burden on FDA to fill open seats on its advisory committees. Vacancy rates have been as high as 24% in FY 2012.
The non-profit group has funded basic research on two multiple sclerosis treatments now in Phase I trials and has agreements with four pharma companies to run assay tests of their compounds.