Teva Wins FDA Nod for Migraine Drug

eva's AJOVYTM Injection, is the First and Only Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults

Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has approved AJOVY (fremanezumab) injection for the preventive treatment of migraine in adults.

The Israeli company’s share price rose 0.64% on Wall Street yesterday to $22.85, giving a market cap of $23.3 billion. In after-hours trading, its share price was up a further 2.88%.

AJOVY is part of class drugs called calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. These antibody drugs work by blocking the CGRP protein, which is associated with migraine pain. It is the first and only anti-CGRP treatment for the prevention of migraine and will be marketed with quarterly (675 mg) and monthly (225 mg) dosage options.

Teva president and CEO Kare Schultz said, “This is an important day for Teva and complements our long-standing history of helping patients living with diseases of the central nervous system. The approval of AJOVY helps us to continue to provide access to important medicines and to deliver on our commitment to our key stakeholders – patients, employees and shareholders.”

AJOVY has been touted as a potential replacement for Teva’s blockbuster branded multiple sclerosis treatment Copaxone, which has seen sales fall from a peak of more than $4 billion annually, since its patent expired and generic copycat versions have come on the market.

AJOVY has been evaluated in two Phase III, placebo-controlled clinical trials that enrolled patients with disabling migraine and was studied as both a stand-alone preventive treatment and in combination with oral preventive treatments. In these trials, patients experienced a reduction in monthly migraine days during a 12-week period.

“With limited availability of preventive treatment options, AJOVY provides physicians with an important new option for their patients,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D at Teva. “This approval furthers our ongoing commitment and experience in neurological conditions like migraine.”

The US Wholesale Acquisition Cost (WAC) of AJOVY is $575 per monthly dose and $1,725 per quarterly dose. AJOVY will be available through retail and specialty pharmacies in two weeks.

 

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