Teva secures FDA approval for Ajovy injection in migraine prevention

Teva Pharmaceutical Industries has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) approving Ajovy (fremanezumab-vfrm) injection for migraine prevention in adults. The approval marks a pivotal advancement in migraine care, positioning Ajovy as the first anti-calcitonin gene-related peptide (CGRP) treatment approved in the United States with both quarterly (675 mg) and monthly (225 mg) dosing options, offering flexibility for patients.

Ajovy, a humanized monoclonal antibody, operates by binding to the CGRP ligand, effectively blocking its receptor binding. This process is crucial for preventing migraines, a condition that impacts over 36 million people in the U.S., with approximately 40% eligible for preventive treatment. According to Teva, Ajovy offers a promising option for these patients, many of whom remain untreated despite their need for preventive care.

New Option for Migraine Patients

The approval follows extensive phase 3 clinical trials, led by Stephen Silberstein, which demonstrated Ajovy’s efficacy and safety. Silberstein highlighted that Ajovy brings an alternative preventive treatment to patients, potentially reducing monthly migraine days and improving life quality. “Migraine is a disabling neurological disease that affects millions. Many remain untreated, making Ajovy a valuable addition to our treatment arsenal,” he said.

Clinical Success and Patient Outcomes

Teva’s Ajovy underwent rigorous testing through two phase 3, placebo-controlled trials. These studies targeted patients with chronic or episodic migraines, evaluating Ajovy both as a stand-alone treatment and in combination with other oral preventive therapies. The trials showed a meaningful reduction in migraine days over 12 weeks, a promising outcome for those struggling with frequent migraines.

Kåre Schultz, President and CEO of Teva, expressed pride in Ajovy’s approval, calling it “an important day for Teva” that reinforces the company’s dedication to central nervous system therapies. He emphasized that Ajovy’s approval demonstrates Teva’s ongoing commitment to providing innovative treatments to patients, which aligns with the company’s mission to benefit key stakeholders—patients, employees, and shareholders.

Ajovy Injection Options and Availability

Ajovy will be available in a 225 mg/1.5mL prefilled syringe, giving patients the choice of two dosing schedules. Patients can receive a monthly 225 mg injection or a quarterly 675 mg injection, administered as three subcutaneous injections, depending on their needs. Teva hopes this flexibility will support patients in managing their migraines more effectively, with minimal interruption to their daily lives.