Teva Pharma (TEVA) Announces FDA Acceptance of Resubmitted NDA for SD-809 for Treatment of Chorea Associated with HD
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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 3, 2017.
“We are delighted to share the news of this step in the regulatory process with the Huntington disease community,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We are committed to continuing our collaboration with the FDA to make this potential treatment option available to patients.”
SD-809 was granted Orphan Drug Designation for the treatment of HD by the FDA in November 2014. The NDA filing is based on results from two Phase-III studies, FIRST-HD and ARC-HD. The resubmission of the NDA follows the receipt of a Complete Response Letter (CRL) from the FDA in May 2016.
SD-809 (deutetrabenazine) is an investigational, oral, small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain. SD-809 is being developed for the treatment of chorea associated with Huntington disease, a neurodegenerative movement disorder that impacts cognition, behavior, and movements.
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