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Teva Announces Positive Recommendation by NICE for first anti-CGRP migraine therapy: AJOVY

Teva Pharmaceutical Europe BV an affiliate of Teva Pharmaceutical Industries Ltd. (NYS:TEVA) today announced that the National Institute for Health and Care Excellence (NICE) has recommended AJOVY (fremanezumab) in its Final Appraisal Document (FAD) for the pr

Benzinga · 03/12/2020 09:14

Teva Pharmaceutical Europe BV an affiliate of Teva Pharmaceutical Industries Ltd. (NYS:TEVA) today announced that the National Institute for Health and Care Excellence (NICE) has recommended AJOVY (fremanezumab) in its Final Appraisal Document (FAD) for the prevention of migraine in adults with chronic migraine. NICE recommends AJOVY® for chronic migraine patients who have not responded to at least three prior preventive drug treatments.

AJOVY® is one of several monoclonal antibodies specifically designed to target the CGRP (calcitonin gene-related peptide) pathway, a key contributor to migraine and is the first anti-CGRP preventive therapy approved by NICE. AJOVY ® is a long-acting treatment that offers monthly or quarterly dosing options and can be self-injected. 1

Until the anti-CGRPs were approved, migraine preventive therapies in Europe were limited and none of the commonly used treatments (anti-epileptics, anti-depressants, beta blockers and botulinum toxin injections) were developed specifically to target the molecular pathways of migraine.2

"NICE's decision to approve the use of AJOVY® on the NHS in England and Wales for patients with chronic migraine is fantastic news," comments Dr Mark Weatherall, President of the British Association for the Study of Headache. "Anyone who looks after people with chronic migraine understands just how debilitating this neurological disorder can be. We have waited a long time for this new class of drug to be made available in the NHS, but now that we can prescribe fremanezumab, I am excited to see what a difference it will make to the lives of many of my worst affected patients," said Dr Mark Weatherall, President of the British Association for the Study of Headache.

Migraine remains under-diagnosed and under-treated in at least 50% of all patients. Less than 50% of people with migraine are not recognized by their general practitioner and less than 30% of migraine patients have management of their disease.3 Migraine typically presents as a moderate to severe throbbing headache, often accompanied by nausea and/or vomiting, with sensitivity to noise, light and/or smell.4

It is estimated that 1 in 7 adults are affected by migraine and women are three times more likely to be affected than men.5 Chronic migraine, defined as 15 or more headache days and at least 8 migraine days per month for more than three months, is estimated to affect around 900,000 6.7 of the adult population in the UK and can have a tremendous impact on quality of life. With 15% of people affected, Europe has the highest percentage of people with migraine of all continents. 8

NICE recommends AJOVY® for chronic migraine patients who have not responded to at least three prior preventive drug treatments. This decision is based on a dossier submitted to NICE for a Single Technology Appraisal (STA). Following issuance of the FAD, NICE will provide its formal guidance to the NHS in England. The full NICE recommendations and conditions can be viewed on their website.

Richard Daniell, Executive Vice President European Commercial, Teva: "This is an important decision to help the lives of migraine patients in England and signifies a recognition of the impact of this disease. Patients' lives and choices are limited by their migraine. We are proud that Teva's AJOVY® is the first anti-CGRP preventive therapy that NICE has considered to demonstrate cost-effectiveness leading to a reimbursement decision. In time we hope that this treatment becomes available for all adult chronic migraine patients across Europe."