European Commission Approves First Oral Disease-Modifying Treatment for MS

December 5, 2018

Novartis has announced that the European Commission has approved Gilenya (fingolimod) as a treatment for children and adolescents (10–17 years) with relapsing-remitting forms of multiple sclerosis (RRMS).

In a Nov. 29, 2018 press statement, Novartis has announced that the European Commission (EC) has approved Gilenya (fingolimod) as a treatment for children and adolescents (10–17 years) with relapsing-remitting forms of multiple sclerosis (RRMS).

This authorization was based on Phase III clinical trial data (PARADIGMS study) and makes Gilenya the first oral disease-modifying treatment for children and adolescents available on the European market.

“We are excited by the news that there is now a new approved treatment indicated for young people with RRMS in Europe-hopefully this will be the first step to having more therapy options for children and adolescents with MS,” said Pedro Carrascal, president, European Multiple Sclerosis Platform. “Young patients affected by MS often experience a more severe impact during their overall lifetime. Today's approval provides an opportunity for a brighter future for them and their families.”

“Early onset MS can have a devastating impact on children and adolescents' daily life, such as going to school and spending time with friends and family,” added Paul Hudson, chief executive officer, Novartis Pharmaceuticals. “Our mission is to change the course of MS as we've been doing since the treatment's initial approval in 2011, and we won't stop until we stop MS. We are delighted that today's decision has brought us one step closer to reimagining the treatment of MS, across all ages.”

This marketing authorization applies to all 28 member states of the European Union, in addition to Iceland, Norway, and Liechtenstein. Initial approval of Gilenya was for the treatment of adults aged 18 years and older with relapsing forms of MS both in the United States and Europe. The therapy received FDA approval for the treatment of children and adolescents 10 years of age and older with MS on May 11, 2018.

Source: Novartis