New preventive treatment for migraine now licensed in Australia 1

Teva Pharma Australia have today announced that AJOVY^® (fremanezumab), an anti-CGRP (or calcitonin gene-related peptide) treatment, is now listed on the Australian Register of Therapeutic Goods (ARTG) for the prevention of migraine in adults. 1 This new treatment option has quarterly or monthly dosing options to help people reduce migraine. 1

Migraine is a debilitating neurological disease. 2 In Australia, 4.9 million people live with migraine, with almost 8% of this group having chronic migraine experiencing 15 or more headache days and eight or more migraine days a month. 2 , 3 Despite the physical and psychological impact of migraine, only one out of five people receives a timely diagnosis.3 Up until now, existing treatments for conditions like epilepsy and depression have been used to treat the disease, often prescribed off-label and showing limited evidence of effectiveness. 4

Carl Cincinnato, Headache Australia, says: “A migraine is more than just a headache. Millions of Australians are struggling with this unpredictable and debilitating neurological disease that can disrupt their personal and professional lives. People living with frequent migraine attacks want a solution that helps them take back control of their lives, with fewer days interrupted by migraine and a chance to enjoy normal lives again. The new class of anti-CGRP preventive treatments is a positive step forward for the community, offering new hope in the management of migraine.” 

Associate Professor Susan Tomlinson, Neurologist at a Leading Sydney Tertiary Hospital, says: “Migraine is a hugely debilitating disease affecting millions of people in Australia. It is often invisible and undertreated, with only a small percentage of patients seeking advice from their GP or pharmacist. The ARTG listing of AJOVY offers people experiencing symptoms a monthly or quarterly dosing option to help prevent the number of migraine days they experience.” 

The new class of anti-CGRPs are the first preventive treatments specifically indicated for migraine to be introduced in Australia. This marks an important progress in the therapeutic management of the disease. Anti-CGRPs address the severe reduction in quality of life experienced by people living with migraine in Australia. 2 , 4

Benet Irish, General Manager at Teva Pharma Australia, says: “We are proud to introduce AJOVY, a new option in the management of migraine. As a global leader for disorders of the central nervous system (CNS), we believe in taking a patient-centric approach to deliver the next generation of innovative medicines. At Teva, we are committed to placing people at the core to enable as many people as possible to live better, healthier days.” 

Teva Pharma Australia has made a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) to ensure that eligible patients will be able to access the treatment via the Pharmaceutical Benefits Scheme (PBS) in the future. If you wish to learn more about AJOVY, please speak to a neurologist.

In relation to this Teva media announcement, no compensation was provided to Carl Cincinnato, and the opinions expressed are their own. Carl Cincinnato has been briefed by Teva on the approved use of this product. 

Dr Tomlinson has served on a steering committee for Teva for which compensation was received. In relation to this Teva media announcement, no compensation was provided to Dr Tomlinson, and the opinions expressed are their own. Dr Tomlinson has been briefed by Teva on the approved use of this product.

AJOVY MINIMUM PRODUCT INFORMATION:

PBS Information: This product is not listed on the PBS

AJOVY (fremanezumab) 225 mg/1.5mL solution for injection in a pre-filled syringe. 

Indication: preventive treatment of migraine in adults.

Contraindications: Hypersensitivity to the active substance or to any other component of the product.

Precautions: Hypersensitivity; consider discontinuation and initiate appropriate treatment, Major Cardiovascular Disease; some patient groups with major cardiovascular disease were excluded from clinical trials. No safety data is available in these patients. No data available in elderly or paediatric patients. No data available in Renal or hepatic impairment. See Full PI. Pregnancy Category B1; may cross placenta. Lactation, unknown whether fremanezumab is excreted in human milk. No or negligible influence on the ability to drive or operate machinery.

Interactions: No formal clinical drug interaction studies have been performed. Concomitant Migraine Treatment; concomitant use of acute migraine treatments (analgesics, ergots and triptans) and preventive migraine medications did not influence safety and efficacy. CYP450 Substrates; pharmacokinetic interactions are not expected when co-administered. See Full PI.

Adverse Effects: Clinical Trials; Very Common: Injection site pain, injection site induration, injection site erythema. Common: Injection site pruritus. Reactions were mild to moderate. Immunogenicity; no significant adverse events related to Anti-Drug Antibodies (ADA) have been reported. Safety and efficacy were not affected by ADA development. See Full PI.

Dosage and Administration: Treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine. Must only be administered by subcutaneous injection. Available in a monthly dose; 225 mg once monthly or a quarterly dose; 675 mg every three months. Switching Dose Regimens; first dose of the new regimen should be administered on the next scheduled dose date of the prior regimen. Missed Dose; resume dosing on the indicated dose and regimen. Do not administer a double dose. Continuity of Treatment; patients should be assessed 8-12 weeks after initiation of treatment and at regular intervals thereafter. May be administered by healthcare professionals as well as patients, and/or caregivers upon proper training from their healthcare professional. Syringe is single use in one patient only. Discard any residue. Follow clean injection technique every time. Administer by subcutaneous injection only into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, do not use the same injection site. Do not co-administer with other injectable drugs at the same injection site.

Instructions for use: Remove from the refrigerator and allow to reach room temperature for 30 minutes prior to use. Do not use if it has been stored unrefrigerated for 14 days or longer, or at temperatures higher than 30°C. The pre-filled syringe should not be shaken. Visually inspect for particles or discolouration prior to administration. AJOVY is a clear to opalescent, colourless to slightly yellow solution. Do not use if the solution is cloudy, discoloured, or contains particles. Do not use if AJOVY is frozen. See Full PI.

Presentation: 1.5 mL solution in a 2.25 mL glass syringe. Pack sizes of one 225mg/1.5mL or three 225mg/1.5mL pre-filled syringes. Not all pack sizes may be marketed.

Storage: Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the pre-filled syringe(s) in the outer carton in order to protect from light. May be stored unrefrigerated for up to 14 days at a temperature up to 30°C. Must be discarded if not used within 14 days of removal from refrigeration. Based on Product Information approved 20th September 2019. Date of minimum PI preparation: 24 September 2019. PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING.

The Product Information can be accessed at http://www.medicines.org.au/files/tbpajovy.pdf or from Medical Information on 1800 AU Teva (1800 28 8382). 

Additional information

About Migraine

Migraine is a complex neurological disorder in which patients experience head pain, nausea, vomiting, and sensory sensitivity to light and sound for up to, or more than, 15 days per month. 2 

In Australia 4.9 million people suffer from migraine, 71% of migraine sufferers are women and 86% are of working age.2

The physical, emotional, and economic burdens of migraine are under-acknowledged.2Nearly all people living with migraine experience reductions in social activities and work capacity. 2 The disease costs Australia $35.7 billion a year, yet only a small percentage of patients seek advice from general practitioners (23%) and pharmacists (11%). 2 , 5

About AJOVY

AJOVY (fremanezumab) is indicated for the prevention of migraine in adults. AJOVY is available as a 225 mg/1.5mL single dose injection in a prefilled syringe with two dosing options – 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), administered as three subcutaneous injections.¹AJOVY can be administered subcutaneously (under the skin) by a health professional, or self-injection at home by a patient or caregiver after receiving appropriate training from a health professional. 1