Teva hopes to launch migraine drug as soon as September

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Teva Pharmaceutical stated on Wednesday it might launch its migraine therapy as quickly as mid-September, after an preliminary delay.

The debt-ridden firm is relying on the drug – fremanezumab – together with Huntington’s therapy Austedo, to assist it return to progress.

Teva and Eli Lilly are in a race to place a second migraine drug available on the market, after rival Amgen received FDA approval final week for Aimovig to stop migraine complications in adults.

Lilly has stated it expects an FDA choice on its galcanezumab drug by the third quarter.

“We’re making ready to launch the product instantly when permitted,” stated Brendan O’Grady, head of Teva’s North America Business division in an announcement. “Migraine sufferers have waited years for brand spanking new preventive therapies to enter the market.”

Israel-based Teva had initially hoped to obtain approval for fremanezumab by June however issues raised by the U.S. Meals and Drug Administration in February over the manufacturing facility at Teva’s companion Celltrion in South Korea delayed approval.

Final month Teva, the world’s largest generic drugmaker, stated it could be delayed till no later than the top of 2018.

Teva stated on Wednesday that the FDA’s prescription drug consumer payment act (PDUFA) motion date was set for Sept. 16, when the FDA will doubtless make its choice on fremanezumab, which is available in month-to-month and quarterly doses.

It famous that there had been no further knowledge requests from the FDA.

“Our main objective is to carry preventive therapy choices to migraine sufferers as rapidly as doable,” stated Hafrun Fridriksdottir, government vice chairman of Teva’s international R&D. “We’re inspired by the continued communications with the FDA as we work to carry this essential remedy to sufferers.”

Teva’s share worth has fallen 30 % since final August as a result of a decline in U.S. generic drug costs and copycat competitors for its blockbuster a number of sclerosis drug Copaxone.

Its shares had been up zero.1 % at $21.03 in early Nasdaq buying and selling.

Teva additionally was saddled with $35 billion in debt from its $40.5 billion buy in 2016 of Allergan’s generic drug enterprise Actavis, forcing it to promote belongings. Its gross debt stood at $30.eight billion as of March 31

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