German pharmaceutical giant Merck has announced the US Food and Drug Administration (FDA) approval of its Mavenclad (cladribine) tablets in various forms of multiple sclerosis (MS).
The indication is for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS), and makes the drug the first and only FDA approved treatment for RRMS and active SPMS that provides two years of proven efficacy with a maximum of 20 days of oral treatment, during a two-year period.
“Multiple sclerosis is the leading cause of non-traumatic disability in young and middle-aged adults,” said Belén Garijo, CEO healthcare and member of the executive board of Merck. “We feel privileged to introduce Mavenclad into clinical practice in the United States. Mavenclad opens a new way to treat MS - a treatment that requires a maximum of 20 days of oral therapy to deliver two years of efficacy to a patient. This approval is a testimony to our long-standing commitment to people living with MS.”
The approval is based on clinical program consisting of more than 9,500 patient years of cladribine data and up to eight years of time on study, which found that 81% of dosed patients were free of relapses after two years of short-course oral treatment with Mavenclad, compared to 63%.
85% of people living with MS are initially diagnosed with RRMS, characterised by attacks of new or increasing neurological symptoms. Most people with RRMS will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function over time.