BOTOX® (Allergan s botulinum toxin type A) Given Final Guidance from the National Institute for Health and Clinical Excellence (NICE) for the Prevention of Chronic Migraine in Patients Who Have Failed Previous Treatments
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BOTOX® (Allergan's botulinum toxin type A) Given Final Guidance from the National Institute for Health and Clinical Excellence (NICE) for the Prevention of Chronic Migraine in Patients Who Have Failed Previous Treatments

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BOTOX® (Allergan's botulinum toxin type A) Given Final Guidance from the National Institute for Health and Clinical Excellence (NICE) for the Prevention of Chronic Migraine in Patients Who Have Failed Previous Treatments PR Newswire MARLOW, England, June 27, 2012 MARLOW, England, June 27, 2012 /PRNewswire/ -- Allergan announced today that the National Institute for Health and Clinical Excellence (NICE) has issued its Final Guidance giving the green light for ®BOTOX (botulinum toxin type A) to be used on the NHS as prophylaxis (prevention) against headache in adults with chronic migraine*, specifically in patients who have not responded to at least three prior preventative treatments and whose condition is appropriately managed for medication [1]overuse. This means that Primary Care Trusts (PCTs) in England and Wales now have 90 days to make funding and resources available to treat patients suffering from this debilitating condition with BOTOX®. Allergan's BOTOX® is the only botulinum toxin type A to have received authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for the [2]prevention of headache in chronic migraine. Wendy Thomas, Chief Executive of The Migraine Trust comments, "This decision is widely welcomed by the migraine community as these patients are frequently debilitated and are often poorly served by the NHS.

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BOTOX® (Allergan's botulinum toxin type A)
Given Final Guidance from the National
Institute for Health and Clinical Excellence
(NICE) for the Prevention of Chronic Migraine in
Patients Who Have Failed Previous Treatments
PR Newswire
MARLOW, England, June 27, 2012
MARLOW,
England
,
June 27, 2012
/PRNewswire/ --
Allergan announced today that the National Institute for Health and Clinical
Excellence (NICE) has issued its Final Guidance giving the green light for
BOTOX
®
(botulinum toxin type A) to be used on the NHS as prophylaxis
(prevention) against headache in adults with chronic migraine*, specifically in
patients who have not responded to at least three prior preventative
treatments and whose condition is appropriately managed for medication
overuse.
[1]
This means that Primary Care Trusts (PCTs) in
England
and
Wales
now have 90 days to make funding and resources available to treat patients
suffering from this debilitating condition with BOTOX®. Allergan's BOTOX® is
the only botulinum toxin type A to have received authorisation from the
Medicines and Healthcare products Regulatory Agency (MHRA) for the
prevention of headache in chronic migraine.
[2]
Wendy Thomas, Chief Executive of The Migraine Trust comments, "This
decision is widely welcomed by the migraine community as these patients are
frequently debilitated and are often poorly served by the NHS. Together with
the British Association for the Study of Headache, we call on decision makers
within the NHS to quickly implement the guidance for BOTOX® in order to
provide access to this valuable treatment option."
Chairman of the British Associations for the Study of Headache Dr Fayyaz
Ahmed said, "As the new NHS evolves, it's imperative that the commissioners
and GP consortia takes into consideration the needs of patients with headache
and migraine. On behalf of BASH, I welcome the decision by NICE to agree that
this potentially life changing treatment can now be offered within the NHS.
However, currently access to BOTOX® as a treatment option for eligible
patients with chronic migraine is patchy across the country and I am hopeful
that this Final Guidance will speed up commissioning of services."
Chronic migraine is a disabling condition that disrupts the lives of patients as
well as their families, with many sufferers unable to work or struggling to
manage household and family responsibilities.
[3]
Patients with chronic migraine
frequently struggle to adequately control their headaches and migraine, often
using many different types of pain relief and preventative medications. While
there are an estimated 730,000 adults in the UK
[4]
with chronic migraine, only
20% of people with the condition are properly diagnosed.
[5]
Allergan estimates
that about a third of diagnosed patients with chronic migraine have already
tried three or more preventative medications and may now be eligible for
treatment with BOTOX®.
Historically, treatment for chronic migraine has consisted of a combination of
acute and prophylactic treatments available either over-the-counter or by
prescription, such as triptans, tricyclic antidepressants, β-blockers and anti-
epileptics. Current prophylactics for migraine are poorly adhered to for a
variety of reasons including tolerability issues, unrealistic expectations of
treatment, and dosing frequency.
[6]
Heather Sim, Chief Executive from the National Migraine Centre says "It's
concerning that nearly 8 in 10 patients with chronic migraine do not have a
formal diagnosis, despite spending more than half of each month suffering
from a headache or migraine. Patients at home struggling to manage their
condition should ask their GP for an appointment with a headache specialist."
The Final Guidance reflects current best clinical care and incorporates
appropriate stopping rules. According to the Final Guidance, treatment with
BOTOX® should be stopped in people whose condition is not adequately
responding to treatment (defined as less than a 30% reduction in headache
days per month after two treatment cycles) or has changed to episodic
migraine (defined as fewer than 15 headache days per month) for three
consecutive months.
"This Final Guidance is tremendous news for patients with chronic migraine who
have tried three different types of medication to manage their condition. The
evidence shows that BOTOX® can provide significant benefit to patients with
chronic migraine, helping to reduce the number of days disrupted by migraine
or headache while improving their quality of life", said Dr Selwyn Ho, Country
Manager, Allergan UK. "It is therefore crucial that the NHS and PCTs act swiftly
to ensure they can provide the necessary services to these patients."
Notes to Editor
Headache diaries
Headache diaries are valuable tools that allows patients to track the number of
days disrupted with a headache or a migraine. Online diaries are available from
the Migraine Trust, Migraine Action or the National Migraine Centre Clinic.
About BOTOX®
BOTOX® is a brand name. It is a prescription-only medication that contains tiny
amounts of highly purified botulinum toxin protein refined from the bacterium,
Clostridium botulinum
. In the UK, BOTOX® is indicated for the treatment of
adult patients with:
[2]
blepharospasm (uncontrolled blinking of the eyelids)
hemifacial spasm (a neuromuscular disorder characterised by unpredictable and
involuntary twitching of facial muscles on one side of the face)
cervical dystonia (a muscle condition affecting the neck making it difficult to hold the
head up straight)
severe axillary hyperhidrosis (excessive sweating) of the armpits
upper limb spasticity (wrist and hand disability associated with stroke in adults)
prophylactic (prevention) of headache in adult patients with chronic migraine
BOTOX® is also approved for the treatment of glabellar lines (frown lines). In
addition, BOTOX® is approved for the treatment of dynamic equinus foot
deformity in paediatric patients with cerebral palsy aged two years and older.
Refer to the Summary of Product Characteristics for full prescribing information
at http://www.medicines.org.uk/emc/medicine/112.
About Allergan
Allergan, Inc. is a multi-specialty health care company established more than
60 years ago with a commitment to uncover the best of science and develop
and deliver innovative and meaningful treatments to help people reach their
life's potential. Today, we have more than 10,000 highly dedicated and talented
employees, global marketing and sales capabilities with a presence in more
than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals,
biologics, over-the-counter medicines and medical devices, and state-of-the-art
resources in R&D, manufacturing and safety surveillance that help millions of
patients see more clearly, move more freely and express themselves more
fully. From our beginnings as an eye care company to our focus today on
several medical specialties, including ophthalmology, neurosciences, obesity,
urologics, medical aesthetics and dermatology, Allergan is proud to celebrate
more than 60 years of medical advances and proud to support the patients and
physicians who rely on our products and the employees and communities in
which we live and work.
Forward-Looking Statement
This press release contains "forward-looking statements", including but not
limited to the statements by Selwyn Ho, Dr. Fayyaz Ahmed, Wendy Thomas,
Heather Simms and other statements regarding the NICE Final Guidance,
likelihood of National Health Service adoption, research and development
outcomes, efficacy, adverse reactions, market and product potential, product
availability and other statements regarding BOTOX®. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual results
could vary materially from Allergan's expectations and projections. Risks and
uncertainties include, among other things, general industry and pharmaceutical
market conditions; technological advances and patents attained by
competitors; challenges inherent in the research and development and
regulatory processes; challenges related to new product marketing, such as the
unpredictability of market acceptance for new pharmaceutical products and/or
the acceptance of new indications for such products; inconsistency of
treatment results among patients; potential difficulties in manufacturing a new
product; general economic conditions; and governmental laws and regulations
affecting domestic and foreign operations. Additional information concerning
these and other risk factors can be found in press releases issued by Allergan,
as well as Allergan's public periodic filings with the U.S. Securities and Exchange
Commission, including the discussion under the heading "Risk Factors" in
Allergan's 2011 Annual Report on Form 10-K and subsequent Quarterly Reports
on Form 10-Q. ® and ™ Marks owned by Allergan, Inc.
References
1. National Institute for Health and Clinical Excellence. Final Guidance:
Botulinum toxin type A for the prevention of headaches in adults with chronic
migraine accessible via http://www.nice.org.uk/TA260 [accessible from
June 27,
2012
]
2. Botox® Summary of Product Characteristics
http://www.medicines.org.uk/EMC/medicine/112/SPC/BOTOX+100+Units/
3. Lipton RB. Chronic Migraine, Classification, Differential Diagnosis and
Epidemiology.
Headache.
2011;51(suppl2): 77S-83S.
4. National Institute for Health and Clinical Excellence. Costing Template:
Botulinum toxin type A for the prevention of headaches in adults with chronic
migraine accessible via http://www.nice.org.uk/TA260 [accessible from
June 27,
2012
]
5. Bigal ME, et al. Chronic Migraine in the Population.
Neurology
. 2008;71:559-
566.
6. Cady R, Schreiber C. Botulinum toxin type A as migraine preventive
treatment in patients previously failing oral prophylactic treatment due to
compliance issues.
Headache.
2008;48:900-13
Media contacts
For any further information please contact:
Janet Kettels, Allergan : kettels_janet@allergan.com or +44(0)7738-506476
Julia Cross, CCA : j.cross@cca-uk.com or +44(0)207-632-1896
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