Merck KGaA Announces Outcome of Its Request for Reexamination of CHMP Opinion for Cladribine Tablets in MS

CHMP confirms its initial negative opinion regarding the marketing authorization application for Cladribine Tablets

25-Jan-2011 - Germany

Merck KGaA announced that following its request for reexamination, the Committee for Medicinal Products for Human Use (CHMP) confirmed its previous position and adopted a final negative opinion regarding the marketing authorization application (MAA) for Cladribine Tablets as a treatment for relapsing-remitting multiple sclerosis (MS).

The majority of CHMP members were of the opinion that the benefits of Cladribine Tablets do not outweigh its risks based on data submitted. However, some CHMP members did not share this opinion and voted in favor of a conditional marketing authorization of Cladribine Tablets for the indication discussed during the reexamination procedure.

“We are disappointed by the CHMP opinion, however we continue to believe that our data support Cladribine Tablets as a treatment option for patients with relapsing forms of MS,” said Dr. Bernhard Kirschbaum, Merck Serono’s Head of Research and Development. “We remain fully committed to the potential of Cladribine Tablets to meet an unmet medical need as an oral, short-course, disease-modifying drug for multiple sclerosis and will evaluate our options for bringing this therapeutic option to patients who could benefit from it also in Europe.”

Merck remains committed to completing the ongoing clinical trials with Cladribine Tablets. The Data Safety Monitoring Board that independently oversees the conduct of these trials recently concluded that they should continue. These trials, which are fully enrolled, will provide additional information on the efficacy and safety of Cladribine Tablets in MS. Top-line results from the CLARITY1 EXTENSION and ORACLE MS2 studies are expected by the end of 2011. Top-line results from the ONWARD3 study are expected in the first half of 2012.

https://www.bionity.com/en/news/130410/merck-kgaa-announces-outcome-of-its-request-for-reexamination-of-chmp-opinion-for-cladribine-tablets-in-ms.html