Posted by Michael Wonder on 19 Dec 2017
Novartis multiple sclerosis therapy fingolimod granted FDA breakthrough therapy designation for paediatric multiple sclerosis
18 December 2017 - In a pivotal Phase III study, oral fingolimod significantly reduced relapses by 82% in a paediatric patient population vs. interferon beta-1a intramuscular injection.
Novartis today announced that the US FDA has granted breakthrough therapy designation for fingolimod for the treatment of children and adolescents 10 years of age or older with relapsing multiple sclerosis (MS). Fingolimod, also known as Gilenya in the US, is approved to treat relapsing forms of MS in adults. Gilenya is not currently approved for children and adolescents with relapsing MS.
The breakthrough therapy designation is based on data from the Phase III PARADIGMS study, which evaluated the safety and efficacy of fingolimod vs. interferon beta-1a in children and adolescents (ages 10 or older) with relapsing MS. PARADIGMS, the first completed randomised, controlled clinical trial specifically designed for paediatric relapsing MS, found that treatment with fingolimod resulted in an 82% reduction in the rate of relapses (annualised relapse rate) in this patient population over a period of up to two years, compared to interferon beta-1a intramuscular injection (p <0.001).
