How Teva Won FDA Approval for Ajovy

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Teva Pharmaceuticals Ltd. (NYSE: TEVA) shares made a solid gain early Monday after the company announced a critical approval by the U.S. Food and Drug Administration (FDA).

Specifically, the FDA approved Ajovy (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults.

For some quick background: Ajovy is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. It is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options.

Previously, Ajovy was evaluated in two Phase 3 clinical trials that enrolled patients with disabling migraine, and it 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.

Note that following this approval, Ajovy will be available through retail and specialty pharmacies in about two weeks.

Stephen Silberstein, M.D., Director, Jefferson Headache Center at Thomas Jefferson University Hospital, and lead investigator of the Phase 3 clinical trial program for Ajovy, commented:

Migraine is a disabling neurological disease that affects more than 36 million people in the United States. About 40% of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.

Just after the opening bell, shares of Teva traded up more than 6% at $24.28, with a consensus analyst price target of $20.83 and a 52-week range of $10.85 to $25.96.