Biohaven Pharmaceutical Holding Company Ltd. today announced that its 505(b)(2) new drug application (NDA) for BHV-0223, an investigational sublingual form of riluzole for the treatment of people living with amyotrophic lateral sclerosis (ALS), has been accepted for review by the U.S. Food and Drug Administration (FDA). Biohaven previously announced that the FDA granted orphan drug designation for BHV-0223 in ALS. BHV-0223 is a novel, lower dose formulation of riluzole designed to be placed under the tongue where it dissolves in seconds and is absorbed sublingually. The active ingredient, riluzole, is the only FDA-approved treatment to extend tracheostomy-free survival in people living with ALS.
ALS is a progressive, neurodegenerative motor neuron disease that affects nerve cells in the brain and the spinal cord. The disease belongs to a group of disorders known as motor neuron diseases, which are characterized by the gradual degeneration and death of motor neurons.
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