FDA Hits Teva With Complete Response Letter for Huntington’s Disease Candidate

The FDA has handed Israeli drug giant Teva Pharmaceutical Industries a complete response letter for its SD-809 candidate for treatment of chorea associated with Huntington’s disease.

According to the drugmaker, the agency is asking the company to examine blood levels of certain metabolites, but is not asking for additional clinical trials.

Michael Hayden, Teva’s president of global R&D and chief scientific officer, says the company plans to submit a response to the agency’s letter sometime this fall.