MediciNova declares FDA approval for MN-166 as orphan drug

Release Date: 14-Nov-2016

Medicinova, a biopharmaceutical company, announced FDA approved orphan drug designation for its leading medical treatment, MN-166 (ibudilast) for the treatment of Amyotrophic Lateral Sclerosis (ALS). Currently, there is only one approved treatment for ALS that is riluzole, present in the market. MN-166 is presently undergoing clinical trials by researchers at Carolinas HealthCare System's (CHS).
Amyotrophic Lateral Sclerosis (ALS) is also called as Lou Gehrig's disease is a progressive neuro-degenerative disease that affects brain and the spinal cord. ALS drains the ability to trigger specific muscles causing weakness in them. It affects the voluntary movement in the patient and causes total paralysis at later stages.


Orphan Drug designation is granted by the FDA's Office of Orphan Products Development for drugs that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients annually. Orphan Drug designation qualifies a company for several benefits under the Orphan Drug Act 1983. These benefits include assistance with clinical study design in drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.


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