Novartis has secured approval from the European Commission (EC) for its Gilenya (fingolimod) to treat children and adolescents, aged between 10 and 17 years, with relapsing-remitting forms of multiple sclerosis (RRMS).
Gilenya is claimed to be the first and only oral disease-modifying treatment approved for children and adolescents in the Europe.
The approval allows the company to market Gilenya in all 28 European Union member states, in addition to Iceland, Norway and Liechtenstein.
In May this year, Gilenya secured approval from the US Food and Drug Administration (FDA) to treat children and adolescents 10 years of age and older with MS.
European Multiple Sclerosis Platform president Pedro Carrascal said: “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.
The approval of Gilenya is based on Paradigms multiple sclerosis phase III clinical trial, which is specifically designed for children and adolescents 10 to 17 years old.
The data from the double-blind, randomized, multi-center study of Gilenya against interferon beta-1a has demonstrated that Gilenya significantly reduced the annualized relapse rates by 82%.
Paradigms study has also showed that around 85.7% of patients treated with Gilenya have been relapse-free at up to 24 months against 38.8% of patients treated with interferon beta-1a.
In addition, the patients treated Gilenya demonstrated a 77% risk reduction of disability progression compared to patients treated with interferon beta-1a.
The company recruited 215 children and adolescents with MS at 80 centers in 25 countries, and is in line with the FDA, European Medicines Agency and the International Pediatric Multiple Sclerosis Study Group.
Novartis Pharmaceuticals CEO Paul Hudson said: “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.
“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.”