Teva’s migraine drug Ajovy (fremanezumab) has moved closer to the EU market after the influential CHMP regulatory committee gave it the green light.
The decision paves the way for European approval, which usually follows a positive opinion from the CHMP within a few months.
Ajovy is one of a group of calcitonin gene-related peptide (CGRP) class drugs that are coming to market.
Novartis was first to market with its CGRP drug Aimovig (erenumab) in Europe, which was approved in July last year.
Teva’s Ajovy has been recommended for prophylaxis of migraine in adults who have at least four migraine days per month.
The injected biologic drug can be given either quarterly or monthly, as opposed to Aimovig, which must be given every four weeks.
Ajovy is important to Teva because the company is in need of new revenues after its $40.5 billion acquisition of Allergan’s generics business left it saddled with debt.
The positive CHMP opinion is based on the review of a filing that included efficacy and safety data from the HALO clinical development programme.
The programme evaluated Ajovy 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.
Richard Daniell, executive vice president, European Commercial at Teva, said: “We are very pleased to report a positive opinion by the CHMP.”
“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.”
February 4, 2019