FDA Grants MediciNova Fast Track for Multiple Sclerosis Drug

FDA has granted MediciNova a fast track designation for MN-166 (ibudilast) and its use in treating patients with progressive multiple sclerosis. MN-166 has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova licensed the drug from Kyorin Pharmaceutical for potential utility in relapse-remitting multiple sclerosis.

The company describes the therapy is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. “It attenuates activated glia cells, which play a major role in certain neurological conditions,” MedicNova says. Ibudilast's anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results, it says.