Teva’s Ajovy (fremanezumab) received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), which often leads to approval by the European Commission (EC).
Teva is looking for Ajovy to become the third anti-calcitonin gene-related peptide (CGRP) treatment on the market, following the entry of Novartis and Amgen’s first-in-class treatment, and Eli Lilly’s product.
The new wave of CGRP-inhibitor treatments are aimed at patients who experience at least four migraine days per month.
Despite being third to the market, Ajovy has the option to be administered at different intervals compared to its two rivals. Both Novartis/Amgen and Lilly’s products require injections every month, while Teva’s product has quarterly and monthly dosing options.
Richard Daniell, EVP of European commercial at Teva, emphasised the differentiator of this dosing regimen in a statement: “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.”
Teva has already received approval for the product in the US. The approval arrived despite a number of manufacturing challenges in recent times, which saw the company’s partner, Celltrion, receive a warning letter and a Form 483 in the space of one year.
Teva expects a final decision to be made by the EC in the first half of 2019.