Otsuka Pharmaceutical Co., Ltd.

July 8, 2021

Otsuka Files Application in Japan for Approval of Auto-Injector Dosage Form for AJOVY® Subcutaneous Injection 225 mg for Preventive Treatment of Migraine

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has applied to Japan's Ministry of Health, Labour and Welfare for an additional dosage form, auto-injector, for AJOVY® Subcutaneous Injection 225 mg (generic name is fremanezumab).

Otsuka received manufacturing and marketing approval of AJOVY Subcutaneous Injection 225 mg Syringe for the indication of preventive treatment of migraine in adult patients in Japan. Approval was granted in June 2021.

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.

AJOVY is an asset of Teva Pharmaceutical Industries Ltd. Otsuka entered into an exclusive license agreement for development and sales in Japan.