Oral Therapies for Multiple Sclerosis – Fingolimod (FTY 720) and Cladribine: How Close are Novartis and Merck KGaA to FDA Approval?

These are interesting days for the first oral therapies targeting multiple sclerosis (cladribine and  fingolimod or FTY720) indeed, with both positive and negative events making news over the last several weeks.  On November 30th 2009,  Reuters reported that the FDA had issued Merck KGaA a ‘refuse to file’ letter, which in effect is the FDA’s way [...]

Elan/Biogen Idec’s Antegren (Natalizumab) for Treatment of Multiple Sclerosis

On July 26, 2004 Elan Corp.’s application for approval of its multiple sclerosis (MS) drug Antegren was accepted for review by the FDA. Elan has developed Antegren with U.S. partner Biogen Idec. The company has stated that this therapy represents a new approach in the treatment of MS and is expected to eventually generate annual [...]