Positive Recommendation by NICE for first anti-CGRP migraine therapy: AJOVY®▼ (fremanezumab)
March 12 2020 - 3:30AM
Business Wire
Teva Pharmaceutical Europe BV an affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: 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.”
-ENDS-
Notes to editors
- AJOVY®▼ Package leaflet Information for the patient.
http://products.tevauk.com/mediafile/id/48238.pdf - Last accessed:
March 2020.
- 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
- Pavone E, et al. ‘Patterns of triptans use: a study based on
the records of a community pharmaceutical department’. Cephalalgia
2007; 27:1000–1004.
- NHS – Migraine (www.nhs.uk/conditions/migraine/symptoms/) Last
accessed: March 2020
- 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: March 2020]
- 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
- 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/annualmidyearpopulationestimates/mid2018
[Last accessed: March 2020]
- [1] Stovner, L. J., Andree, C. 2010. Prevalence of headache in
Europe: a review for the Eurolight project [Online] Available from:
https://link.springer.com/article/10.1007/s10194-010-0217-0
[Accessed on 13 September 2018]
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 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. Full product information can be accessed
from the Teva website:
http://products.tevauk.com/p/fremanezumab-728?productId=19035
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
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. Learn more at www.tevapharm.com.
About NICE
The National Institute for Health and Care Excellence (NICE) 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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding AJOVY®, which are based on management’s current beliefs
and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- the commercial success of AJOVY;
- our ability to successfully compete in the marketplace,
including: consolidation of our customer base and commercial
alliances among our customers; competition for our specialty
products; and competition from companies with greater resources and
capabilities;
- our business and operations in general, including manufacturing
or quality control problems; interruptions in our supply chain
including due to potential effects of the COVID-19 outbreak on our
operations in geographic locations impacted by the outbreak and on
the business operations of our customers and suppliers; and
challenges associated with conducting business globally, including
adverse effects;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2019, including in the sections
captioned "Risk Factors” and “Forward Looking Statements.”
Forward-looking statements speak only as of the date on which they
are made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
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