AJOVY

What it is

AJOVY is a solution for injection containing 225 mg fremanezumab in 1.5 mL, available as a single-dose pre-filled syringe or autoinjector. Fremanezumab is a fully humanised monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology. Fremanezumab potently and selectively binds the calcitonin gene-related peptide (CGRP) ligand and blocks both CGRP isoforms (α- and β-CGRP) from binding to the CGRP receptor, preventing the activation of the trigeminal system.

Approved indications

— Preventive treatment of migraine in adults.

Dosing overview

Two dosing options are available: 225 mg once monthly (monthly dosing) or 675 mg every three months (quarterly dosing). The treatment benefit should be assessed 8–12 weeks after initiation of treatment. AJOVY should only be administered by subcutaneous injection.

Key safety warnings

Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity and urticaria, were reported with fremanezumab in clinical trials and in the post-marketing setting, occurring in less than 1% of patients in clinical trials. Anaphylactic reactions have been reported rarely with fremanezumab, mostly occurring within 24 hours of administration although some reactions have been delayed. In the post-marketing period, Stevens-Johnson Syndrome was reported in one patient taking multiple concomitant medications including lamotrigine and treated with fremanezumab, and this reaction has also been rarely reported in patients taking other anti-CGRP monoclonal antibodies with concomitant medications including lamotrigine. Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including AJOVY, in the post-marketing setting, with some patients who developed new-onset hypertension having risk factors for hypertension, and cases requiring initiation of pharmacological treatment for hypertension and in some cases hospitalisation, occurring most frequently within 7 days of therapy initiation. Patients treated with AJOVY should be monitored for new-onset hypertension or worsening of pre-existing hypertension, and discontinuation of AJOVY should be considered if evaluation fails to establish an alternative aetiology or blood pressure is inadequately controlled. The most frequently reported adverse events were local reactions at the injection site: pain (24%), induration (17%), erythema (16%) and pruritus (2%).

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

AJOVY solution for injection 225 mg in 1.5 mL is listed on the PBS as single-dose pre-filled pen and single-dose pre-filled syringe formulations, with streamlined restriction, at an ex-manufacturer price of A$488.89.

Regulatory history

The pre-filled syringe formulation (ARTG 308630) was first listed on 20 September 2019, and the autoinjector formulation (ARTG 342612) was first listed on 2 June 2021. In March 2020, the PBAC recommended AJOVY for listing for chronic migraine prophylactic treatment in adult patients who had experienced inadequate response, intolerance or a contraindication to at least three prior preventive migraine medications. In March 2022, the PBAC recommended a change to allow quarterly dosing and approved the new auto-injector form under the same conditions as pre-filled syringes. In November 2022, the PBAC recommended AJOVY for high-frequency episodic migraine with inadequate response, intolerance or contraindication to at least three prophylactic migraine medications.