Teva Pharmaceutical said on Wednesday it could launch its migraine treatment as soon as mid-September, after an initial delay.
The debt-ridden company is counting on the drug – fremanezumab – along with Huntington’s treatment Austedo, to help it return to growth.
“We are preparing to launch the product immediately when approved,” said Brendan O’Grady, head of Teva’s North America Commercial division in a statement. “Migraine patients have waited years for new preventive treatments to enter the market.”
Israel-based Teva had initially hoped to receive approval for fremanezumab by June but concerns raised by the U.S. Food and Drug Administration in February over the manufacturing facility at Teva’s partner Celltrion in South Korea delayed approval.
Last month Teva, the world’s largest generic drugmaker, said it would be delayed until no later than the end of 2018.
Teva said on Wednesday that the FDA’s prescription drug user fee act (PDUFA) action date was set for Sept. 16, when the FDA will likely make its decision on fremanezumab, which comes in monthly and quarterly doses.
It noted that there had been no additional data requests from the FDA.
“Our primary goal is to bring preventive treatment options to migraine patients as quickly as possible,” said Hafrun Fridriksdottir, executive vice president of Teva’s global R&D. “We are encouraged by the ongoing communications with the FDA as we work to bring this important therapy to patients.”
Teva’s share price has fallen 30 percent since last August due to a decline in U.S. generic drug prices and copycat competition for its blockbuster multiple sclerosis drug Copaxone.
Its shares were up 0.1 percent at $21.03 in early Nasdaq trading.
Teva also was saddled with $35 billion in debt from its $40.5 billion purchase in 2016 of Allergan‘s generic drug business Actavis, forcing it to sell assets. Its gross debt stood at $30.8 billion as of March 31