Teva Gets a Complete Response Letter for Huntington Disease Drug
James Radke, PhD
Teva Pharmaceutical Industries received a Complete Response Letter (CRL) from the FDA regarding their drug SD-809 (deutetrabenazine) to treat chorea associated Huntington disease (HD).
Details of why the FDA rejected the drug are not clear but in a press release, Teva said the FDA has asked the company to examine blood levels of certain metabolites but that no new clinical trials have been requested.
Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva said the company plans to submit their response to the Complete Response Letter in the third quarter of this year.
Recently, we talked with Samuel Franks, MD of Beth Israel Deaconess Medical Center about the efficacy of SD-809 to treat chorea and dystonia in patients with Huntington's disease. Click the image below to watch a clip from that interview.