Novartis announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of Gilenya for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis, or RRMS. If approved, Gilenya is expected to be the first oral disease-modifying therapy indicated for these patients based on a randomized controlled clinical study. The younger patient population experiences two-to-three times as many relapses as adults, often leading to a more severe prognosis and earlier disability compared to adult-onset MS. If approved, Gilenya would address the urgent need faced by these young people. This market authorization would expand the age range of Gilenya, one of the most prescribed MS treatments worldwide. Gilenya was previously approved for adults with RRMS aged 18 years and older in Europe.
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