A new migraine treatment that Teva Pharmaceutical Industries was hoping would be approved this year will likely not be OK’d for the U.S. market until 2019.
The FDA recently raised concerns about a manufacturing facility owned by one of the company’s partners in South Korea, signaling a longer wait for approval.
Teva had banked on the possibility that the drug, fremanezumab, could help lift the company out of a dismal past year that included 14,000 announced layoffs in 2017. Making matters worse, U.S. buyers are lobbying Amgen to lower the price of its rival migraine medication and offer a money-back guarantee. If they succeed, it will put downward pricing pressure on fremanezumab as it enters the market.
Eli Lilly is also expected to win approval for its new migraine medication, galcanezumab, this year.
Read the full Reuters report.