• Lupin: FDA Grants Mexiletine Orphan Drug Designation For Myotonic Disorders

    • June 8, 2020
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    India-based Lupin Limited announced Monday that the US Food and Drug Administration or FDA has granted Orphan Drug Designation or ODD to mexiletine hydrochloride for the treatment of myotonic disorders.

    Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called myotonia.

    According to the firm, myotonia is an inability to relax a contraction of skeletal muscle which originates from a voluntary muscular contraction.

    Mexiletine reduces myotonia symptoms, resulting in a significant improvement in patient quality-of-life and other functional outcomes.

    The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

    Vinita Gupta, CEO of Lupin, said, “The decision by the US FDA to grant orphan drug designation to mexiletine brings us closer to providing a licensed treatment option for patients in the US.”


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