FDA Approves Orphan Status to Ibudilast in ALS

October 17, 2016

FDA granted orphan-drug designation to ibudilast (MN-166) for treatment of amyotrophic lateral sclerosis, known as ALS or Lou Gehrig’s disease.

Ibudilast has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova, the drug’s sponsor, is developing ibudilast for progressive MS, ALS, and other neurological conditions, as well as substance abuse and addiction.

Drugs that receive orphan-drug designation from FDA are entitled to seven years of marketing exclusivity if they are approved by the FDA for the same rare disease.

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