teva_copy

FDA asks Teva for further study on Huntington drug candidate

pharmafile | June 1, 2016 | News story | Medical Communications, Research and Development Huntington disease, Teva, US FDA, regulation 

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) said the US regulators have put on hold the approval for its drug to treat chorea caused by Huntington disease (HD) and asked for additional blood study.

The company said it received a letter from the Food and Drug Administration (FDA) for the drug compound SD-809, to treat chorea, or abnormal, involuntary writhing movements that occur in 90% of HD patients at some point in the course of their illness.

The world’s largest generic drug firm said the FDA has asked it to examine blood levels of certain metabolites. These metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine. No new clinical trials have been requested, the company said in a statement.

Michael Hayden, chief scientific officer at Teva, said: “We are accelerating the re-analysis process we were asked to conduct. We plan to submit our response to the CRL in Q3 2016.”

Anjali Shukla

Related Content

louis-reed-pwckf7l4-no-unsplash_5

Sanofi and Teva partner for development of inflammatory bowel disease treatment

Sanofi and Teva Pharmaceuticals have announced that they will collaborate for the co-development and co-commercialisation …

vitaminsupplementpills

‘Smart drugs’ may contain unapproved pharmaceuticals, according to a new study

Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and …

covid-19-4922384_640

COVID-19: UK and Europe life sciences regulatory developments

Marie Manley, Partner, and Bethany Wise, Trainee Solicitor, at Sidley Austin look at UK and …

Latest content