Teva Pharmaceutical Gets Positive CHMP Opinion For Ajovy - Quick Facts

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency (EMA) has recommended granting a marketing authorization for Ajovy or 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.

If approved by the European Commission or EC, Ajovy, a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, will be the first and only anti-CGRP treatment in the European Union or EU, 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 50 million people suffering from the disease across Europe. It is estimated that the total annual cost of migraine in Europe is 111 billion euros.

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

The program 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 or ADRs 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.

Teva said it expects a final decision in the first half of 2019.