Two CGRP-Targeting Migraine Therapies—Teva’s Ajovy and Amgen’s Aimovig—Approved in Japan for Preventive Treatment of Adult Migraine
Jun 24, 2021 15:04
CST Updated
15:04
Teva
Drug Developer
June 24, 2021 /BioonBIOON/ -- Teva Pharmaceutical Industries (Teva Pharma) recently announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Ajovy (fremanezumab) injection for the preventive treatment of migraine in adults. In Japan, the annual prevalence of migraine in the adult population is 8.4%.
Ajovy is the first and only long-acting anti-calcitonin gene-related peptide (CGRP) subcutaneous injection for the preventive treatment of migraine, offering once-monthly and once-quarterly (every 3 months) dosing options.
As part of an exclusive licensing agreement in May 2017, Ajovy is being developed in Japan by Otsuka Pharma with the assistance and collaboration of Teva. Earlier in 2020, both parties announced the results of two pivotal clinical trials evaluating Ajovy for the treatment of episodic migraine (EM) and chronic migraine (CM) conducted in Japan. In both trials, Ajovy demonstrated clinically and statistically significant improvements in the primary endpoints compared with placebo. Furthermore, Ajovy also showed statistically significant improvements across all secondary endpoints relative to placebo. Regarding safety, Ajovy was well tolerated compared with placebo, with a similar incidence of adverse events.
On the same day, Amgen also announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved its Aimovig (erenumab) for the preventive treatment of migraine in adults. In Japan,Aimovig is the first and only treatment that blocks the calcitonin gene-related peptide receptor (CGRP-R).
The approval of Aimovig in Japan was based on the results of a Phase 2 clinical study (20120309) and a Phase 3 clinical study (20170609). The Phase 2 study evaluated the safety and efficacy of Aimovig for the treatment of episodic migraine in Japanese adults, while the Phase 3 study evaluated the efficacy and safety of Aimovig for the treatment of episodic migraine and chronic migraine in Japanese adults. In both studies, Aimovig significantly reduced monthly migraine days (MMD) from baseline at Months 4, 5, and 6 of the double-blind treatment period (DBTP). The safety and tolerability of Aimovig were also consistent with previous global data. The most commonAdverse Reactions(≥1%) include constipation, injection site reactions, and somnolence.
Migraine is a common chronic neurovascular disorder characterized by recurrent attacks of severe headache, typically unilateral. Currently, there is no medication available to cure migraine. The World Health Organization (WHO) has listed migraine as one of the top 10 most disabling diseases.
Calcitonin gene-related peptide (CGRP) is a neuropeptide that has been shown to be released during migraine attacks and is considered a trigger for migraine attacks. Currently,CGRP and its receptor (CGRP-R) have become prominent targets for migraine drug development.
To date, four monoclonal antibody-based migraine therapies targeting CGRP/CGRP-R have been approved for marketing, besidesBesides Aimovig (targeting CGRP-P) and Ajovy (targeting CGRP), it also includes Lundbeck's Vyepti (targeting CGRP),Eli LillyEmgality (CGRP-targeted)Regarding administration, both Aimovig and Emgality are administered via subcutaneous injection once a month, Ajovy can be administered subcutaneously once a month or once every three months, and Vyepti is administered via intravenous infusion once every three months. (Bioon.com)