EU approval for Teva’s quarterly dosed migraine drug

09-Apr-2019 - Last updated on 09-Apr-2019 at 09:55 GMT

(Image: Getty/seb_ra)

Teva’s anti-CGRP migraine drug lines up next to its competitors as the European Commission grants it marketing authorization.

Ajovy (fremanezumab), developed by Teva Pharmaceutical, is a pre-filled injection for the prophylaxis of migraines in adults. The drug is a humanized monoclonal antibody (mAb) that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Ajovy received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) in February 2019. It is recognized as the first CGRP treatment with both quarterly and monthly dosing options.

Novartis has also experienced regulatory success in the CGRP space and received the first-in-class approval for Aimovig (erenumab). Eli Lilly also received approval of its anti-CGRP drug, Emaglity (galcanezumab).

According to Teva, Ajovy will have a list price of $575 (€491) per monthly dose and $1725 per quarterly dose.

Prior to the drug’s US Food and Drug Administration (FDA) and EU approval, the producer of the active pharmaceutical ingredient (API) for the drug, Celltrion, received both an FDA warning letter and a Form 483.

However, shortly after issuing regulatory warnings, the FDA approved Ajovy as a preventative treatment of migraine in adults as the regulatory issues were not related to the manufacturing of the API needed to produce the drug.