FDA Grants Orphan Drug Status to ALS Treatment
MediciNova announced that the Food and Drug Administration (FDA) has granted orphan drug designation to MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS).
The designation is based on positive interim efficacy data from a mid-study analysis of two currently ongoing clinical trials evaluating MN-166 in ALS. The trials are in collaboration with researchers at Carolinas HealthCare Systems (CHS) Neuromuscular/ALS-MDA Center and Massachusetts General Hospital.
MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. The treatment has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma.
Riluzole is currently the only pharmaceutical treatment approved for ALS. There are approximately 30,000 ALS patients in the U.S. with approximately 5,600 newly diagnosed each year, according to the ALS Association.
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