CHMP positive for Gilenya to treat children and adolescents with relapsing remitting multiple sclerosis . Novartis

Novartis has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis (RRMS). If approved, Gilenya is expected to be the first oral disease-modifying therapy indicated for these patients based on a randomized controlled clinical study.

The younger patient population experiences two-to-three times as many relapses as adults, often leading to a more severe prognosis and earlier disability compared to adult-onset MS. If approved, Gilenya would address the urgent need faced by these young people. This market authorization would expand the age range of Gilenya, one of the most prescribed MS treatments worldwide. Gilenya was previously approved for adults with RRMS aged 18 years and older in Europe.

The CHMP positive opinion is based on the PARADIGMS trial, a first-of-its-kind clinical study in MS specifically designed for children and adolescents aged 10 to 17 years. Results from the double-blind, randomized, multi-center Phase III study of Gilenya vs. interferon beta-1a show that compared to interferon beta-1a, Gilenya significantly reduced the annualized relapse rates by 82% (relative difference to interferon beta-1a, p<0.001) and delayed the time to first relapse. furthermore it also significantly reduced the number of new or newly enlarged t2 lesions up to 24 months by 53 p><0.001) and the annualized rate of brain volume loss brain shrinkage by 40. the full paradigms data was recently published in the new england journal of medicine.>

See--"Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis"- Tanuja Chitnis, M.D., Douglas L. Arnold, M.D., Brenda Banwell, M.D.,et al.-September 13, 2018. N Engl J Med 2018; 379:1017-1027 DOI: 10.1056/NEJMoa1800149.