Oral multiple sclerosis treatment cladribine has been rejected by the European Medicines Agency’s Committee for Medicinal Products.
The regulator denied Merck marketing authorisation for the drug as treatment for relapsing-remitting multiple sclerosis, stating that its benefits did not outweigh its risks based on the data available.
The German drug manufacturer has said it is evaluating all options to gain approval within the European Union.
The news follows the approval of Novartis’ MS drug Gilenya by the US Food and Drug Administration, placing the Swiss pharmaceutical firm ahead of Merck in the race to market an multiple sclerosis medication.