Otsuka Pharmaceutical Co., Ltd.
Otsuka Obtains Approval in Japan for Auto-Injector Dosage Form for AJOVY®
Subcutaneous Injection 225 mg for Preventive Treatment of Migraine
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has received regulatory approval in Japan on June for an additional dosage form, auto-injector, for AJOVY® Subcutaneous Injection 225 mg (generic name is fremanezumab).
The auto-injector formulation contains 225 mg of flemanezumab (one dosage unit) and can be administered by removing the protective cap and pressing the injector against the injection site. The injection needle is concealed by a needle cover, designed to prevent needlestick accidents. In addition, the fact that the needle is not visible to the patient during administration of the drug may reduce their anxiety or fear of injection.
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 with Teva for development and sales in Japan.