Merck KGaA's oral multiple sclerosis drug Mavenclad (cladribine) should finally get approved and launched in the US in the first half of 2019, executives at the German company told Scrip. It will be helped in part by the deep data collected during its difficult regulatory journey spanning nine years,which should differentiate the therapy from other MS drugs, they believe.
Mavenclad has had a difficult past: The German drug maker first filed the product in 2009 but was pushed back by regulators, largely because of concerns about increased cancer risk in the two-year Phase III CLARITY trial. (Also see "Merck KGaA Pins Cladribine Hopes On Ongoing Studies After Complete Response Letter" - Pink Sheet, 2 March, 2011