The FDA said that it approved Merck KGaA's Mavenclad (cladribine) to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. The company noted that the drug is the first treatment authorised in the US in this indication "that provides two years of proven efficacy with a maximum of 20 days of oral treatment, during a two-year period."
According to the FDA, because of its safety profile, Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS, and should not be used in patients with clinically isolated syndrome. Meanwhile, the product's label includes a boxed warning for potential risk of malignancy and risk of teratogenicity.
Mavenclad was approved in Europe in 2017, while the FDA accepted Merck's filing seeking approval of the drug last year. The agency had originally rejected the therapy in 2011, asking for an improved understanding of the safety risks and the overall benefit-risk profile.
The FDA noted that approval of Mavenclad was based on efficacy data from a study of 1326 patients with relapsing forms of MS who had least one relapse in the previous 12 months. Results showed that Mavenclad significantly decreased the number of relapses experienced by these patients compared to placebo, whilst the drug also reduced the progression of disability.
Sales of Mavenclad, which is authorised in 50 countries, reached 90 million euros ($101 million) last year, up from 5 million euros ($6 million) in 2017.
For related analysis, see KOL Views: Assessing the impact of new entrants Mavenclad, Mayzent on MS market.
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