EU approves first treatment for children and adolescents with relapsing-remitting multiple sclerosis

MADRID, 29th November (EUROPA PRESS) –

Novartis announced Thursday that the European Commission had approved the use of "Gilenya & # 39; (fingolimod) to treat children and adolescents aged 10 to 17 years with relapsing forms of multiple sclerosis (RRMS), making this medication the first and only approved oral disease-modifying therapy for these patients.

The young population with MS needs to opt for effective treatment, since it has two to three times more epidemics than adults, which is usually associated with a more severe prognosis and more severe disease. an early irreversible disability in relation to MS in the adult. , according to Pedro Carrascal, of the European Platform of Multiple Sclerosis.

"We are delighted to learn that an approved treatment has been approved for young people with RRMS in Europe, based on a Phase III controlled clinical trial." Young patients with MS often suffer from a more serious impact of the disease throughout today's approval offers these children and their families the opportunity to have a better future, "commented Carrascal.

In the same vein, Novartis Pharmaceuticals Executive Director Paul Hudson emphasized that early childhood MS can have a "devastating effect" on the lives of children and adolescents and affect their daily lives. l & # 39; school. time with your friends and family. "Our mission is to change the course of MS, as we have done since the initial approval of treatment in 2011, and we will not stop until we have stopped MS. that today 's decision has brought us closer to reinventing the treatment of MS at all ages, "he said.

The European Commission's approval is based on the "PARADIGMS" trial, a phase III clinical trial on MS specifically designed for children and adolescents aged 10 to 17 years. The results of the multicenter double-blind randomized "Gilenya" versus interferon beta-1a study show that it significantly reduces the annualized rate of 82% and 85.7% of patients treated with the drug. They remain unscathed from outbreaks until 24 months.

The decision of the European Commission is applicable to the 28 Member States of the European Union, as well as to Iceland, Norway and Liechtenstein. Gilenya was initially approved for adults over 18 years of age with recurrent forms of multiple sclerosis in the United States and Europe. The drug Novartis has received approval from the US Food and Drug Administration (FDA) to treat children and adolescents aged 10 years and older on May 11.