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Merck Serono Europe informed the European Medicines Agency that it was withdrawing its marketing authorization application for oral cladribine (Movectro), 10-mg tablets, intended for the treatment of relapsing-remitting multiple sclerosis.
Merck Serono Europe informed the European Medicines Agency (EMA) that it was withdrawing its marketing authorization application for oral cladribine (Movectro), 10-mg tablets, intended for the treatment of relapsing-remitting multiple sclerosis.
In its official letter, the company stated that its decision to withdraw the application was based on the EMA’s Committee for Medicinal Products for Human Use’s (CHMP) negative opinion of the data available to date, reported Medical News Today. The CHMP is responsible for preparing the EMA’s opinions on all questions concerning medicines for human use.
“Movectro was regarded to be a key launch candidate for the German company-with the orally active drug consolidating its already strong multiple sclerosis therapy reputation in the United States, as Merck Serono-along with Pfizer- markets the blockbuster interferon therapy Rebif [interferon beta-1a] in the United States,” John Bird, senior analyst, at Datamonitor Healthcare, told Formulary.
According to Bird, if Merck KGaA decides to withdraw Movectro from the U. S. regulatory process, the company forfeits forecasted sales of $350 million by 2015 for this region, alone.
It has been reported that FDA will complete its review of the drug by February 28. Meanwhile, Novartis’ Gilenya (fingolimod 0.5 mg) won FDA approval last year for the treatment of relapsing forms of MS.
“Failure to gain FDA approval for Movectro in the United States will further enhance Novartis’ position in the lucrative oral MS market,” Bird said.
According to the EMA’s CHMP website, in September 2010, the CHMP had concerns about Movectro’s safety. An increased number of patients with cancer were observed in clinical trials with Movectro compared to the control group. The CHMP also 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. Therefore, at that time, the CHMP said that the benefits of Movectro did not outweigh its risks and recommended refusal of marketing authorization. In January 2011, the CHMP’s main concerns were not resolved during the re-examination procedure. In particular, it was still concerned about Movectro’s long-term safety, even if it were to be used in the restricted group of patients. Therefore the Committee confirmed its initial negative opinion.
Merck Serono Europe told CHMP that it intends to continue clinical trials with Movectro, which so far has only been approved in Australia and Russia.
According to the National Multiple Sclerosis Society, approximately 400,000 Americans have MS, and every week about 200 people are diagnosed. MS affects about 2.5 million people worlwide.