Teva launches pre-filled pen for anti-CGRP migraine therapy AJOVY®▼ (fremanezumab) in the UK
On 21st July 2020, Teva UK Limited announced that a pre-filled pen for AJOVY® (fremanezumab) injection is now available, which will give patients on AJOVY® added convenience and flexibility not previously available with the AJOVY® pre-filled syringe. Indicated for the prevention of migraine in adults who have at least 4 migraine days per month, AJOVY® offers quarterly and monthly dosing options. It is the first and only anti-CGRP drug recommended for use on the NHS in England and Wales by the National Institute for Health and Care Excellence (NICE) for chronic migraine patients. Within NHS Scotland, it is accepted for restricted use by the Scottish Medicine Consortium (SMC) for chronic and episodic migraine.1 AJOVY® is an option for migraine patients who have not responded to at least three prior preventive treatments.1
“Chronic migraine is a debilitating neurological disorder which can, without the right treatment, strike at any time leaving the sufferer feeling helpless,” comments Dr Mark Weatherall, Chair of the British Association for the Study of Headache. “Fremanezumab is well tolerated, effective and particularly useful for complex migraine patients, where other treatments have failed. Patients are often worried about using traditional syringes to inject themselves. A pen device is simple to self-administer and increases patients’ control over their own management of their condition.”
“As healthcare professionals, we want to be able to get patients onto migraine specific treatments expediently. However, headache/migraine specialist clinics are often challenged by high caseloads,” adds Neurology Nurse Prescriber Rebecca Stuckey, University Hospitals Plymouth NHS Trust, “A pen device which patients can easily self-administer will reduce appointments and waiting times. This option will also be welcomed by my patients, who can travel 2-3 hours to the clinic for appointments.”
Previously migraine prevention therapies were limited to treatments repurposed from other disease areas (such as beta-blockers, anti-epileptics, anti-depressants and botulinum toxin injections).2 Botulinum toxin, requiring a minimum of 31 injections into the head or neck per treatment, has to be administered by a healthcare professional at a specialist centre.3 AJOVY® belongs to a class of treatments called anti-CGRP (calcitonin gene-related peptide) monoclonal antibodies, which have been specifically designed to target the underlying causes of migraine. AJOVY® is the only long-acting anti-CGRP injection with the option of dosing four times or twelve times per year using either a pre-filled syringe or the new pre-filled pen. The new AJOVY® pre-filled pen has several features that make it easy-to-use including a button-free, push-down mechanism, audible cues that signal progress of administration, and a window that displays when the dose has been delivered.4 Additionally, the pre-filled pen is for one-time use only and locks after use. AJOVY® can be injected into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red or indurated. Injection sites should be alternated/ rotated.5 It was developed in the UK at Teva’s research and development site in Abbots Park, Runcorn, Cheshire.
“At our Combination Product and Device R&D site in Runcorn we developed the AJOVY® pre-filled pen out of a deep desire to improve the lives of chronic migraine sufferers,” said Paul Bridges, Senior Director CPD R&D at Teva UK’s Abbots Park, R&D site in Runcorn, Cheshire. “We’re really proud that the pre-filled pen was designed and developed here in the UK, and will offer more user friendly treatment options for patients with migraine.”
“We’re delighted to now be able to offer the option of a pre-filled pen device for AJOVY® patients in the UK,” said Kim Innes, General Manager of Teva UK and Ireland. “Earlier this year AJOVY® was the first anti-CGRP medicine recommended by NICE, and we’re pleased to be able to offer people struggling with migraine even greater flexibility and control over their treatment.” Patients may self-inject at home once instructed in subcutaneous self-injection technique by a healthcare professional. This has the potential to free up NHS resources such as nurse or consultant time.
Patients can use the Rain Free Days application for guidance about using AJOVY®, and instructional videos are available from products.tevauk.com. Teva is also providing a fully funded Homecare service which includes training by a nurse.
About AJOVY® (fremanezumab)
AJOVY® (fremanezumab) is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month. AJOVY® is available as a 225mg/1.5mL single dose injection in a pre-filled syringe or pre-filled pen with two dosing options – 225mg monthly administered as one subcutaneous injection, or 675mg every three months (quarterly), administered as three subcutaneous injections. Like all injections, there is a chance of a skin reaction around the injection site e.g. redness, hardness or itching. AJOVY® can be administered at home by a patient or caregiver, if instructed by a healthcare professional. Full product information can be accessed from the Teva website: http://products.tevauk.com/p/ fremanezumab-728?productId=19035 • The Scottish Medicines Consortium (SMC) accepted AJOVY® for restricted use within NHS Scotland (January 2020), for the treatment of patients with chronic and episodic migraine who have had prior failure on three or more migraine preventive treatments. The guidance can be viewed online on the SMC website: https://www.scottishmedicines.org.uk/medicines-advice/fremanezumab-ajovy-fullsmc2226/ • National Institute for Health and Care Excellence (NICE) recommended AJOVY® (fremanezumab) for use within NHS England and Wales (June 2020) for the prophylaxis of migraine in adults with chronic migraine who have not responded to at least three prior preventive treatments. The technology appraisal guidance can be viewed online on the NICE website: https://www.nice.org.uk/guidance/ta631
1. The Migraine Trust – www.migrainetrust.org/living-with-migraine/treatments/calcitonin-gene-related-peptide-pathway-monoclonalantibodies/. Last accessed: July 2020
2. Khan S. et al. ‘CGRP, a target for preventive therapy in migraine and cluster headache: Systematic review of clinical data’. Cephalalgia (2019); 39(3): 374-389
3. Botox® SmPC. Allergan Ltd. 2019. Available at www.medicines.org.uk/emc/product/859/smpc
4. Two Human Factor studies assessed evaluators’ ability to complete critical tasks in order to demonstrate use of the AJOVY Autoinjector in simulated-use sessions. When asked “Was the autoinjector easy to use?”, 97% in study 1 (N=30) and 98% in study 2 (N=47) answered “Yes.” Data on file, Parsippany, NJ Teva Pharmaceuticals USA, Inc.
5. AJOVY® SmPC. Teva UK Ltd. 2019. Available at https://www.medicines. org.uk/emc/product/10386/smpc. Last accessed: July 20206. Pavone E. et al. ‘Patterns of triptans use: a study based on the records of a community pharmaceutical department’. Cephalalgia (2007); 27: 1000-1004.
7. NHS – Migraine (www.nhs.uk/conditions/ migraine/symptoms/) Last accessed: July 2020
8. Migraine Trust – Facts and Figures https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/ (figure based on current UK adult population from the Office of National Statistics – www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/articles/overviewoftheukpopulation/february2016) Last accessed: July 2020
9. Buse DC. et al. ‘Chronic Migraine Prevalence, Disability, and Sociodemographic Factors: Results From the American Migraine Prevalence and Prevention Study’. J Head Face Pain; 52: 1456-1470. doi:10.1111/j.1526- 4610.2012.02223.x
10. Chronic migraine population calculated by using 12% of migraine population (1 in 7 total population) as cited by Buse (above) amongst context of current UK population statistics from Office of National Statistics. Population estimates for the UK, England and Wales, Scotland and Northern Ireland: mid-2018. https:// www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/ populationestimates/bulletins/annualmidyearpopulati onestimates/mid2018 Last accessed: July 2020
AJO-UK-NP-00007 Date of Preparation: July 2020