LONDON (dpa-AFX) - German drug major Merck KgaA (MKGAY.PK) announced that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has issued a positive opinion for approval of Cladribine Tablets (proposed tradename MAVENCLAD) for the treatment of relapsing forms of multiple sclerosis or RMS in patients with high disease activity.
In patients with high disease activity, post hoc analyses of the two-year Phase III CLARITY trial demonstrated that Cladribine Tablets reduced the annualised relapse rate by 67% and the risk of 6-month confirmed EDSS progression by 82% versus placebo. As demonstrated in the Phase III CLARITY EXTENSION study no further Cladribine treatment was required in Years 3 and 4.
The comprehensive data set has informed the posology and monitoring requirements. The most important side effects are lymphopenia, which can be severe and long-lasting, and infections,including herpes zoster.
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