Ajovy is a humanised monoclonal antibody developed as a prophylaxis of migraine. Credit: Business Wire.

Teva Pharmaceutical Industries has secured positive recommendation from the European Medicines Agency (EMA) panel to grant a marketing authorisation for its drug Ajovy (fremanezumab) as a prophylaxis of migraine.

Ajovy is a humanised monoclonal antibody designed to bind to the calcitonin gene-related peptide (CGRP) ligand and prevent its binding to the receptor.

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Teva is seeking approval for 225mg solution of the drug in pre-filled syringe to treat adults experiencing at least four migraine days per month.

Positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is based on efficacy and safety results from the HALO clinical development programme, which comprised of two pivotal Phase III clinical trials.

Conducted in patients with disabling migraine, the drug caused a significantly larger decrease in migraine days in trial participants, compared to placebo.

Adverse drug reactions (ADRs) related to the drug were mostly mild to moderate, such as pain, hardening, redness, itching and rash at the injection site.

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“We hope to expand the availability of Ajovy to the EU so that eligible patients can potentially benefit from the flexibility Ajovy offers through quarterly and monthly dosing options.”

The CHMP recommendation will be considered by the European Commission (EC) for granting the marketing authorisation to the drug in the European Union (EU). Teva expects to receive a final decision in the first half of this year.

Teva European Commercial executive vice-president Richard Daniell said: “This is another important milestone for us and the migraine community as a whole.

“We hope to expand the availability of Ajovy to the EU so that eligible patients can potentially benefit from the flexibility Ajovy offers through quarterly and monthly dosing options.”

The company secured the US Food and Drug Administration (FDA) approval for the migraine drug in September last year.

The drug is said to be the only anti-CGRP migraine treatment with quarterly (675mg) and monthly (225mg) dosing options.