Otsuka Pharmaceutical Co., Ltd.

August 30, 2021

Otsuka to Launch AJOVY® Subcutaneous Injection 225 mg Syringe in Japan

- Two dosing options for preventive treatment of migraine -

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that AJOVY® Subcutaneous Injection 225 mg Syringe (generic name is fremanezumab) will be launched in Japan for the indication of preventive treatment of migraine in adult patients. It will become available from August 30, 2021.

AJOVY is a subcutaneous injection of an 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.

AJOVY is an asset of Teva Pharmaceutical Industries Ltd. Otsuka entered into an exclusive license agreement for development and commercialization in Japan. In addition, Otsuka has filed application in Japan for approval of auto-injector dosage form for AJOVY.

About migraine

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

  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.