Sanofi/Genzyme MS Drug Lemtrada Scores High Against Rebif
This article was originally published in The Pink Sheet Daily
Genzyme, a Sanofi company, set the bar high for its multiple sclerosis contender by stacking it up against Roche’s interferon beta-1a in Phase III trials and got the results it was looking for, with a filing set for this quarter.
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The company says a data formatting issue was the reason FDA declined to accept the supplemental application for alemtuzumab for relapsing multiple sclerosis.
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.
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.