Novartis Announces EU Approval of Gilenya

Novartis announced the European Commission (EC) 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 authorization 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.

"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," said 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."

The EC's approval is based on the PARADIGMS trial, a landmark Phase III clinical study in MS, specifically designed for children and adolescents 10 to 17 years old. Results from the double-blind, randomized, multi-center study of Gilenya vs. interferon beta-1a show that Gilenya significantly reduced the annualized relapse rates by 82% (compared to interferon beta-1a, p<0.001) and 85.7% of patients treated with Gilenya were relapse-free at up to 24 months, versus 38.8% of patients treated with interferon beta-1a (p<0.001). Patients treated with Gilenya also showed a 77% risk reduction of disability progression relative to patients treated with interferon beta-1a. Furthermore, it also significantly reduced the number of new or newly enlarged T2 lesions up to 24 months by 53% (compared to interferon beta-1a, p<0.001) and the annualized rate of brain volume loss (brain shrinkage) by 40% (compared to interferon beta-1a, p=0.014). The full PARADIGMS data were published in The New England Journal of Medicine in September 2018.

The EC decision is applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein. Gilenya was initially approved for adults aged 18 years and older with relapsing forms of multiple sclerosis in the US and Europe. Gilenya received FDA approval for the treatment of children and adolescents 10 years of age and older with MS on May 11, 2018.

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