CHMP Gives Novartis Positive Recommendation for MS Drug

CHMP recommended that Gilenya 0.5 mg daily could be used as a therapy for patients with highly active relapsing-remitting MS.

CHMP (Committee for Medicinal Products for Human Use) approved Novartis’s Gilenya. CHMP recommended that Gilenya 0.5 mg daily could be used as a therapy for patients with highly active relapsing-remitting MS.

Novartis points out that CHMP’s decision on Gilenya was based on the largest clinical trial program submitted to date for a new MS medication. Gilenya, licensed from Mitsubishi Tanabe Pharma, if approved would be the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. In MS the immune system damages the covering that protects nerve fibers in the central nervous system (CNS). Gilenya is thought to work by reducing the immune system’s attack on the CNS by retaining lymphocytes in the lymph nodes, Novartis explains.