Company says it is committed to getting Cladribine approved in EU and has three trials ongoing.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has upheld its previous negative opinion on Merck KGaA’s oral multiple sclerosis (MS) candidate, Cladribine tablets, following the firm’s request that it reexamine the previously submitted trial data. Merck says that although some CHMP members voted in favor of a conditional marketing authorization for the drug, the majority concluded that the benefits of Cladribine did not outweigh the risks.
Merck’s disclosure that the CHMP won’t yet be swayed on Cladribine coincides with Biogen Idec reporting that the committee has separately given a negative opinion on its MS drug Fampyra® (prolonged-release fampridine 10 mg tablets), which has been developed to improve walking ability in patients with MS. Novartis, on the other hand, received a positive recommendation from CHMP on its MS medication, Gilenya.
Merck has reiterated its commitment to the development of Cladribine, which is already approved in Austria and Russia under the tradename Movectro® for the treatment of relapsing-remitting MS. Regulatory review is also under way in other countries, including the U.S., where the application has been granted priority review. Meanwhile, Merck has three additional Cladribine studies ongoing, which are all fully enrolled. Top-line data from the Clarity Extension and Oracle MS studies is expected by the end of 2011. Top-line results from the Onward trial could be available in the first half of 2012.
“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,” comments Bernhard Kirschbaum, Ph.D., Merck Serono’s head of R&D. “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.”
CHMP’s initial recommendation against approving Cladribine was made in September 2010. The EMA notes that at that time its committee had concerns about the medicine’s safety. “An increased number of patients with cancer were observed in clinical trials with Movectro compared to the control group,” EMA points out. Moreover, the agency continues, the committee noted that the benefits and the most appropriate dosage for treatment had not been fully established in patients who were expected to use the medicine. It basically couldn’t conclude that the benefits of Movectro outweighed its risks.
These concerns have apparently not changed. EMA says it remained concerned about Movectro’s long-term safety, even if the medicine were to be used in the restricted group of patients.