Israel’s Teva Pharmaceutical has received marketing authorisation from the European Commission (EC) for Ajovy (fremanezumab), an injection intended to provide relief from migraines.
Adults who suffer at least four migraine days per month will be eligible to be treated with the drug, a 225mg solution in a pre-filled syringe.
Ajovy is a humanised monoclonal antibody (mAb) that targets and binds to the calcitonin gene-related peptide (CGRP) ligand. The drug prevents the ligand’s binding to the receptor.
Data from two pivotal Phase III clinical trials of fremanezumab as a prophylactic treatment showed a significant decrease in migraine days, compared to a placebo. These trials enrolled adults with disabling migraines.
Fremanezumab-related adverse drug reactions (ADRs) observed during the studies were mostly short-term flare ups in the skin around the injection site, such as pain, hardening, redness, itching and rash.
Ajovy is available in quarterly, as well as monthly dosing options, depending in the individual needs of patients. The quarterly dose is administered as three subcutaneous injections, which allows 675mg of the drug into the bloodstream.
Teva Pharmaceutical European Commercial executive vice-president Richard Daniell said: “Migraine can have a significant impact on the day-to-day life of patients with some experiencing 15 headache days per month.
“It is our hope that Ajovy will provide patients and European healthcare professionals with a preventive treatment, which offers patients more migraine free days, as well as greater flexibility in managing this unpredictable disease.”
The approval is applicable to all 28 European Union (EU) member states, as well as Iceland, Norway and Liechtenstein.
Teva received positive recommendation from the European Medicines Agency (EMA) panel in February this year to grant a marketing approval for the drug.
In September last year, the US Food and Drug Administration (FDA) approved the drug for the preventive treatment of migraine in adults with disabling migraines.