FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Novartis MS Drug Scores EC Approval

Dec. 10, 2018
A A

The European Commission approved Novartis’ Gilenya (fingolimod) for treatment of children and adolescents with certain forms of multiple sclerosis.

The drug is indicated specifically for relapsing-remitting forms of MS, the first and only oral disease-modifying treatment for children and adults based on clinical Phase III data. The Phase III clinical trial showed the drug reduced the annualized relapse rates by 82 percent, and 85.7 percent of patients were relapse-free at up to 24 months.

The approval applies to all 28 EU member states as well as Liechtenstein, Norway and Iceland. It received FDA approval in May 2018.

View today's stories