Posted by Michael Wonder on 23 Sep 2018
Novartis receives positive CHMP opinion for Gilenya for the treatment of children and adolescents with MS, marking a major medical advance for young MS patients in Europe
21 September 2018 - Positive opinion is based on the landmark Phase III PARADIGMS trial, which showed Gilenya (fingolimod) substantially reduced the debilitating impact of MS in young patients.
Novartis today announced the CHMP of the 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.
