Teva Receives Positive Committee for Medicinal Products for Human Use Opinion for Ajovy for the Prophylaxis of Migraine in Adults
1 February 2019 - - The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended granting a marketing authorisation for Ajovy (fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month, Israeli drugmaker Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) said.

If approved by the European Commission, Ajovy, a humanised monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor, will be the first and only anti-CGRP treatment in the European Union with both quarterly and monthly dosing options.

Migraine is a disabling neurological disease often accompanied by nausea, vomiting, photophobia, phonophobia and changes in vision.

Globally, there are approximately one billion people affected by migraine, with more than 50m people suffering from the disease across Europe.

It is estimated that the total annual cost of migraine in Europe is EUR 111bn.

The positive CHMP opinion is based on the review of a Marketing Authorization Application that included efficacy and safety data from the HALO clinical development program.

The programme evaluated fremanezumab in two pivotal Phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylaxis of migraine in adults.

In these trials, patients treated with fremanezumab had a significantly greater reduction in migraine days compared to placebo.

Adverse drug reactions observed with Ajovy were mostly mild to moderate, short-lasting skin reactions around the injection area: pain, hardening, redness, itching and rash at the injection site.

The positive CHMP opinion is a formal recommendation to grant the marketing authorization for AJOVY in the EU.

The recommendation will now be reviewed by the EC, which has authority to approve medicines for use in the 28 countries of the EU. A final decision is expected in the first half of 2019.

Teva Pharmaceutical Industries is in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory.