The U.S. Food and Drug Administration (FDA) has denied the New Drug Application (NDA) for Cladribine Tablets, EMD Serono’s proprietary investigational oral medication to treat the relapsing-remitting form of multiple sclerosis (MS).

“The company will work closely with the FDA to fully understand FDA’s concerns and define a path forward for a successful resubmission of this application at the earliest point in time,” Elmar Schnee, Member of the Executive Board Merck KGaA and Head of Pharmaceuticals said in a recent press release. “We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options.”

The FDA has 60 days to review NDA submissions and determine if it the submission is sufficiently complete to permit a substantive review. The FDA issues a refuse to file letter to the applicant, in this case EMD Sereno, if it believes the submission is not sufficiently complete.

It has been reported that the company plans to request a meeting with the FDA as soon as possible to discuss its comments on the NDA submission and to reach an understanding on what would be required for the Cladribine Tablets NDA to be accepted for review.

Cladribine is one of a handful of investigational oral medications being researched to treat MS. Swiss drug manufacturer Novartis,  is also currently conducting Phase III clinical trials for an oral MS drug called Fingolimod (FTY720). Previous trials have shown FTY720 to be effective in preventing MS relapses in more than 60% of patients that were given the pill for three years.

There are a number of other pharmaceutical companies also vying to produce the first MS pill, including Teva Pharmaceutical (Laquinimod), Biogen Idec (BG-12), and Sanofi-Aventis (Teriflunomide). However, experts estimate that these manufacturers may still be a few years behind Merck Sereno and Novartis in acquiring FDA approval.

This entry was posted on Wednesday, December 2nd, 2009 at 9:13 am and is filed under News Alerts. You can follow any responses to this entry through the RSS 2.0 feed.