Generics
Positive Recommendation by NICE for First Anti-CGRP Migraine Therapy Ajovy
12 March 2020 - - The National Institute for Health and Care Excellence has recommended Ajovy (fremanezumab) in its Final Appraisal Document for the prevention of migraine in adults with chronic migraine, Teva Pharmaceutical Europe BV an affiliate of Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) said.

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. 

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.

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.

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.

It is estimated that 1 in 7 adults are affected by migraine and women are three times more likely to be affected than men.

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 %age of people with migraine of all continents. 

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. 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.

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 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.

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.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) has been developing and producing medicines to improve people's lives for more than a century.

We are a leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area.

Around 200m people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry.

Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products.

The National Institute for Health and Care Excellence is an executive non-departmental public body of the Department of Health in the United Kingdom, which publishes guidelines on the use of health technologies (such as the use of new and existing medicines) as well as clinical practice.
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