Merck announces withdrawal of MS drug from markets after FDA safety concerns
Darmstadt – Germany’s Merck KGaA will stop marketing of its multiple sclerosis (MS) pill cladribine (Movectro) in Australia and Russia where it has been already approved. The decision came several month after the US Food and Drug Administration said the company had to provide more data to demonstrate a positive benefit-risk ratio. Merck said yesterday that is was very unlikely to address the FDA requirements without carrying out additional costly clinical trials. Last autumn, the European Medicines Agency finally rejected authorisation of the symptomatic treatment of relapsing-remitting MS in Europe, the largest intended market of the drug, due to occurrence of cancer in some patients involved in a clinical trial. "The FDA feedback was consistent with the feedback previously received from the European Medicines Agency," the company said. Merck's cladribine, a chlorinated purine nucleoside analogon, which induces apoptosis after integration into the DNA, had initially been regarded as a formidable contender in the race with Novartis to bring the first oral treatment against MS to the market. Novartis received US authorisation for its sphingosine-1-phosphate receptor modulator fingolimod (Gilenya) last autumn, challenging the US$ 10 billion market share of MS injectables. The occurrence of cancer casts a bad light on cladribine, approved as a injectable treatment for hair cell leukemia.