US FDA Approves Teva's Ajovy Injection Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults
17 September 2018 - - The US Food and Drug Administration has approved Ajovy (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults, Israeli drugmaker Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) said.

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

Ajovy was 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. The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

The US Wholesale acquisition Cost of Ajovy is USD 575 per monthly dose and USD 1,725 per quarterly dose. Ajovy will be available through retail and specialty pharmacies in approximately two weeks.

There is a savings offer for Ajovy.

Commercially insured patients may pay as little as USD 0 on prescriptions for Ajovy until the offer expires.

Teva Shared Solutions is available to provide support services for patients and offices. Visit to learn more.

Ajovy is indicated for the preventive treatment of migraine in adults. Ajovy is available as a 225 mg/1.5mL single dose injection in a prefilled syringe with two dosing options 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), administered as three subcutaneous injections.

Ajovy can be administered in office by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.

Contraindications: Ajovy is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with Ajovy in clinical trials.

Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration.

If a hypersensitivity reaction occurs, consider discontinuing Ajovy and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

Please for full Prescribing Information for Ajovy (fremanezumab-vfrm) injection.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) is a leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory.