Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that AJOVY^® Subcutaneous Injection 225 mg Syringe (generic name is fremanezumab) has received manufacturing and marketing approval in Japan for the indication of preventive treatment of migraine in adult patients.

AJOVY is a subcutaneous injection of the anti-CGRP (calcitonin gene-related peptide) monoclonal antibody, which is produced by recombinant DNA technology. CGRP is thought to play an important role in migraine attacks. Ajovy targets the CGRP ligand, inhibiting its binding to the CGRP receptor.

AJOVY can be administered in two dosing options, either 225 mg once every four weeks or 675 mg once every 12 weeks. The latter dosing option is a unique feature of this drug in its drug class.

Migraine is a neurological disorder with a high prevalence, estimated to affect over 10 percent of adults worldwide.^*1 In Japan the annual prevalence was estimated at 8.4 percent, and the prevalence was highest among women in their 30s, reaching approximately 20 percent.^*2

Makoto Inoue, president and representative director of Otsuka Pharmaceutical, commented, "Patients with migraine not only suffer the pain of headaches, but also endure a range of disabling symptoms impacting their daily lives, such as the uncertainty of when the next migraine attack will occur, and the difficulty of communicating with those around them when they are suffering the symptoms of an attack. While using the experience we have accumulated to address the problems faced by patients, we hope to give support to the lives of many patients by providing AJOVY as a new treatment option to those in need."

AJOVY is an asset of Teva Pharmaceutical Industries Ltd.

1. 1U.S. National Institute of Neurological Disorders and Stroke, 2013
2. 2Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia 1997; 17(1): 15-22.