Approval for Israel-based Teva Pharmaceutical Industries' drug to treat the neurological disorder chorea has been held up by U.S. regulators seeking further blood studies, the company said on Tuesday.
Approval for Israel-based Teva Pharmaceutical Industries’ drug to treat the neurological disorder chorea has been held up by U.S. regulators seeking further blood studies, the company said on Tuesday.
Teva, the world’s largest generic drugmaker, said the request by the U.S. Food and Drug Administration was made in the watchdog’s Complete Response Letter for SD-809 for the treatment of chorea stemming from Huntington’s disease (HD).
Chorea is a disorder that results in abnormal, involuntary writhing movements that occur in 90 percent of HD patients at some point in the course of their illness.
“The FDA has asked Teva to examine blood levels of certain metabolites,” Teva said, adding that these molecule deposits are also found in subjects treated with tetrabenazine or deutetrabenazine and that no new clinical trials have been requested.
The company, which is in the process of a $40.5 billion deal to buy the generic drug portfolio of Allergan, said it will work closely with the FDA to bring the drug to market as quickly as possible.
“We are accelerating the re-analysis process we were asked to conduct. We plan to submit our response … in the third quarter of 2016,” said Michael Hayden, Teva’s chief scientific officer.
Teva’s New York-listed shares dipped on opening but were up 0.1 percent at $51.67 by 1432 GMT. Shares of Neurocrine Biosciences, which has a rival HD drug in development, jumped 8.4 percent to $50.03.
“While we expect weakness in the stock associated with this event … we continue to like Teva and expect the stock to rebound after the company introduces longer-term guidance in September,” Irina Koffler, a managing director at Mizuho Securities, wrote in a client note.
Koffler, who rates Teva a “buy”, said it was unclear whether the FDA review cycle would be two or six months but now expects the drug to launch in 2017.
RBC Capital’s Randall Stanicky said he believes the delay will have limited impact on earnings expectations and that the drug’s approval could come in the fourth quarter.