Ajovy

Generic name: Fremanezumab

Trade name: Ajovy

All names: Remanezumab, Remantizumab recombinant syringe, Fremanezumab, Ajovy

Indications:

AJOVY is a calcitonin gene-related peptide antagonist, suitable for the preventive treatment of migraine in adults.

Dosage:

Adults, 225 mg fremanesumab (gene recombinant) administered subcutaneously every 4 weeks, or 675 mg administered subcutaneously every 12 weeks.

Strength:

225mg

Adverse reactions:

The most common adverse reaction (≥5% and greater than placebo) is injection site reaction.

Contraindications:

None

Precautions:

Hypersensitivity: If a hypersensitivity reaction occurs, consider discontinuing AJOVY and administering appropriate treatment

Storage:

Store in 2-8°C

Mechanism of action:

Fremanezumab is a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide (CGRP) and inhibits the binding of both isoforms (α- and β-CGRP) to the CGRP receptor, with high affinity for CGRP. α-CGRP: KD=159pM, β-CGRP: KD=112pM) and selective, and does not bind to CGRP-related peptides (amylin, calcitonin and intermediates). A transient weak interaction with adrenomedullin was observed (this affinity is approximately 20,000 times weaker than that of CGRP). Since plasma CGRP levels are elevated during attacks in migraineurs and administration of CGRP to migraineurs induces migraine attacks, Fremanezumab induces migraine attacks by inhibiting CGRP activity and is thought to inhibit.

Safety and efficacy:

The approval of Ajovy is based on data from the Phase III clinical development project HALO. The project includes two pivotal Phase III clinical studies (HALO-EM, HALO-CM), enrolling more than 2,000 patients with episodic migraine (EM) and chronic migraine (CM), and evaluating the efficacy and safety of Ajovy's monthly and quarterly subcutaneous injection dosage regimens. Data from the program showed that monthly and quarterly subcutaneous treatments with Ajovy achieved clinically meaningful and statistically significant improvements compared with placebo across all endpoints and all prespecified analyses: significant reductions in monthly migraine and headache days, significant reductions in rescue medication use and disability, and significant improvements in quality of life. In terms of safety, the most common adverse events were induration, erythema and pruritus at the injection site, with similar incidence rates in the placebo and Ajovy treatment groups.