Novartis has received the thumbs up for Gilenya (fingolimod) and Lucentis (ranibizumab) in Europe.
The European Commission has granted approval for Gilenya as a disease modifying therapy for relapsing-remitting multiple sclerosis (RRMS).
The CHMP has also given a positive opinion on Lucentis to treat visually impaired patients due to macular oedema secondary to retinal vein occlusion (RVO).
David Epstein, Head of Novartis Pharmaceuticals (pictured), said the company was “dedicated to bringing innovative new treatments to patients where there is significant unmet need” and was pleased with both decisions.
The convenient Gilenya capsule 0.5 mg daily has been granted approval for patients with RRMS patients despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS.
Its approval was based on the largest clinical trial program submitted to date for a new MS drug. Data from the studies showed significant efficacy in reducing relapse, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI).
Professor Hans-Peter Hartung, Professor and Chairman, Dept. of Neurology, Heinrich-Heine University, Germany, says Gilenya’s approval is “an important step forward” for patients.
Lucentis’ positive opinion was also based on data from two Phase III studies in patients with Branch RVO (BRAVO) and Central RVO (CRUISE). Studies showed that nearly 60% of BRVO and almost half (48%) of CRVO patients treated with monthly Lucentis gained at least 15 letters of visual acuity at six months, compared with 29% and 17% of those treated according to current standard practice, respectively.
“If approved, Lucentis would be the first anti-VEGF therapy licensed for the treatment of RVO in Europe,” said David Epstein.
“This would be in addition to the Lucentis approvals for patients with wet age related macular degeneration and patients with vision loss due to diabetic macular edema.”
Lucentis is currently licensed in more than 85 countries for the treatment of wet age-related macular degeneration (AMD) and in the European Union for visual impairment due to diabetic macular edema.