Teva Pharmaceutical Industries Ltd. 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.
[adsense:336x280:8701650588]
“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.
