Teva's Preventive Migraine Treatment Approved By FDA

Teva Pharmaceutical Industries Ltd (ADR) ADR TEVA — has struggled amid sagging sales of its blockbuster multiple sclerosis treatment Capaxone due to a generic launch in 2017 and its debt burden following the purchase of Allergan plc AGN's generic unit — has received some relief from the FDA. 

The Israeli drugmaker's migraine drug was approved late Friday.

The U.S.-listed shares of Teva were surging more than 6 percent to $24.28 in premarket trading Monday. 

What Happened

Teva said the FDA approved Ajovy, chemically a fremanezumab-vfrm injection, for the preventive treatment of migraine in adults.

In May, the original PDUFA date for the BLA was extended by three months to Sept. 16, with the manufacturing conditions at one of Teva's South Korean partners cited as the reason for the delay.

Ajovy is a humanized antibody that binds to calcitonin gene-related peptide ligand and blocks its binding to the receptor. It is available in a quarterly dose of 675 mg and monthly dose of 225 mg.

Why It's Important

Migraines affect over 36 million people in the U.S., and about 40 percent of them are responsive to preventative treatment, although most of them are currently untreated, Teva said in a press release. 

The drug is priced at $575 per monthly dose and $1,725 per quarterly dose.

Only recently, the FDA approved the Amgen, Inc. AMGN-Novartis AG (ADR) NVS combo's migraine drug Aimovig, priced at $575 per month.

What's Next

Teva said Ajovy will be available through retail and specialty pharmacies in about two weeks. It has also run a promotion for the drug, with commercially insured patients paying as little as zero on prescriptions for Ajovy until the offer expires.

With two migraine drugs cleared, two more are waiting in the wings: Eli Lilly And Co LLY's galcanezumab, which is expected to be approved by the third quarter, and Alder Biopharmaceuticals Inc ALDR's eptinezuma.

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