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Home > News from MSAA > Oral Cladribine Denied FDA Approval
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Oral Cladribine Denied FDA Approval

March 2, 2011

EMD Serono, Inc., makers of Cladribine Tablets (an oral formulation of cladribine), announced today that they received a complete response letter (CRL) from the United States Food and Drug Administration (FDA). The FDA issues a CRL when it has completed the review of an application. However, in this situation, the FDA was not able to approve the application without additional information. The announcement was disappointing to members of the MS community, who were hoping to see another option added to the list of available disease-modifying therapies for the long-term treatment of MS.

According to EMD Serono, the FDA found substantial evidence of Cladribine Tablets' effectiveness as indicated by the CLARITY study ( CLAdRIbine Tablets treating MS orallY ). While the effectiveness was not in question, the FDA is looking for an improved understanding of safety risks and the overall benefit-risk profile. This will require either additional analysis of presently available data, or additional studies to be conducted.

The drug company plans to request an end-of-review meeting with the FDA. During such a meeting, EMD Serono would find out how to proceed and if data from completed and ongoing clinical studies with Cladribine Tablets could be sufficient to answer the FDA's questions about safety.

EMD Serono notes that they remain committed to completing their ongoing studies with Cladribine Tablets and to continue to seek FDA approval of their drug. Three ongoing studies are nearing completion, and top-line results (the initial, primary outcomes of a study) are expected by the end of 2011 and in the first half of 2012. The safety data from these studies should provide valuable, additional safety data for the FDA to consider.

Background Information

Cladribine is an investigational oral drug being studied for the long-term treatment of relapsing forms of multiple sclerosis (MS). It was submitted to the United States Food and Drug Administration (FDA) for approval and received Fast Track status in July 2010. Fast Track status reduces the FDA's review time from 10 months down to six - and a decision was expected by November 28, 2010. However, the agency extended the review time by three months, with a decision anticipated by February 28, 2011.

While Cladribine Tablets were approved earlier this year in Australia and Russia (under the trade name Movectroi®), European regulators issued a negative opinion in regard to whether the benefits outweigh the risks. Merck Serono (a division of Merck KGaA) plans to appeal this negative decision, which came from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. This rejection was issued in September 2010, prior to the FDA extending its review period of the drug.

For more information on Cladribine Tablets and related studies, please see MSAA's online news article, "FDA Extends the Review Period for Oral Cladribine".

Anyone with questions may call MSAA's Helpline at (800) 532-7667 to speak with a consultant.

Written by Susan Wells Courtney, MSAA Senior Writer & Creative Director
Reviewed by Dr. Jack Burks, MSAA Chief Medical Officer

Last Updated on Wednesday, 17 October 2012 09:14