Posted by Michael Wonder on 29 Nov 2018
Novartis announces EU approval of Gilenya for children and adolescents with MS, making it the first and only oral disease-modifying treatment for these patients in Europe
29 November 2018 - Approval based on landmark PARADIGMS study showing Gilenya (fingolimod) significantly reduced relapse rates by 82% vs interferon beta-1a; additionally, 85.7% of Gilenya patients were relapse-free at two years.
Novartis today announced that the European Commission has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS). The European market authorisation makes Gilenya the first and only oral disease-modifying treatment for children and adolescents based on clinical Phase III data.
This young population living with MS have a critical need for an effective treatment option, as they experience two-to-three times as many relapses as adults, often leading to a more severe prognosis and earlier irreversible disability compared to adult-onset MS.
