GUILDFORD, England,
June 22, 2018 /PRNewswire/ --
- Positive recommendation for
Dupixent[R] (dupilumab) in
Final Appraisal Determination
(FAD) paves the way for the first targeted biologic for adults with
moderate to severe atopic dermatitis
- Atopic dermatitis is the most common type of
eczema,[2] affecting approximately 1.5
million adults in the UK[3],[4]
- Patients with inadequately controlled moderate to severe
atopic dermatitis can face significant physical and psychological
burdens of the disease[5]
The National Institute for Health and Care Excellence (NICE) has
published a positive Final Appraisal Determination (FAD)
recommending dupilumab, in combination with topical
corticosteroids, for routine use on the National Health Service
(NHS) in England for the treatment
of moderate to severe atopic dermatitis in adults when they have
not responded to at least one other systemic therapy (e.g.
immunosuppressants) or these are contraindicated or not tolerated.
Typically healthcare systems in Wales and Northern
Ireland will implement NICE guidance.
(Logo:
https://mma.prnewswire.com/media/700818/Sanofi_Logo.jpg )
"Atopic dermatitis is a long-term, inflammatory disease which
can be a debilitating condition that not only impacts the skin, but
can have a detrimental effect on a patient's mental wellbeing and
quality of life," said Professor Graham
Ogg, Professor of Dermatology, University of Oxford and Consultant Dermatologist,
Oxford University Hospitals NHS Trust.
"NICE's recommendation for dupilumab represents a much needed step
change in the management of moderate to severe atopic dermatitis
and offers an important new treatment for those living with the
disease."
Atopic dermatitis (also known as atopic eczema) is the most
common form of eczema.[2] In the United Kingdom, approximately 1.5 million (3%)
adults have atopic dermatitis.[3],[4] Within the general
UK population, it is estimated that there are 14 adults per 100,000
with moderate atopic dermatitis and 6 adults per 100,000 with
severe atopic dermatitis who may be eligible for treatment with
dupilumab.[6]
Moderate to severe atopic dermatitis is characterised by rashes
often covering much of the body, and can include intense,
persistent itching and skin dryness, cracking, redness, crusting,
and oozing.[2],[7] Itch is one of the most burdensome
symptoms for patients and can be debilitating. In addition, people
with moderate-to-severe atopic dermatitis experience impaired
quality of life, including disrupted sleep, and increased anxiety
and depression symptoms along with their disease.[5]
"This decision is a great step forward for patients with
moderate to severe atopic dermatitis, who will now be one step
closer to accessing dupilumab through the NHS in England," commented Andrew Proctor, Chief Executive at the National
Eczema Society (NES). "Dupilumab represents a new way of treating
atopic dermatitis and we are delighted that NICE has recognised the
huge challenges that some patients face in successfully managing
their condition. The decision gives real hope to people who
desperately need more effective
treatment."
The recommendation in the FAD is expected to form the basis for
NICE's final Technology Appraisal Guidance (TAG) on the use of
dupilumab, anticipated on 1 August,
2018. When medicines introduced through the Early Access to
Medicines Scheme (EAMS) scheme receive a positive NICE final
guidance, the NHS is obliged to provide funding for them in
England within 30 days of NICE
guidance (instead of 90 days for non-EAMS commissioning).
The Medicines and Healthcare products Regulatory Agency (MHRA)
acknowledged the innovative nature of Dupixent[R] ▼
(dupilumab) designating it as a Promising Innovative Medicine and
accelerating its journey to patients through the EAMS.
Peter Kuiper, General Manager
UK & Ireland at Sanofi Genzyme
added: "Throughout the development of dupilumab we have seen,
spoken to and worked around the world with clinicians, patient
groups, and most importantly patients, and have witnessed the
profound impact that atopic dermatitis can have on individuals and
their families. Seeing first-hand the difference that dupilumab can
make to patients' lives has given us the drive and determination to
ensure it becomes available to those who need it as quickly as
possible."
In Scotland, the outcome of an
assessment by the Scottish Medicines Consortium (SMC) is expected
towards the end of 2018.
About Dupixent[R]
(dupilumab)
Dupixent[R] (dupilumab) is a human monoclonal
antibody that is designed to specifically inhibit overactive
signaling of two key proteins, IL-4 and IL-13, which are believed
to be major drivers of the persistent underlying inflammation in
atopic dermatitis.[8] Dupixent[R] (dupilumab)
was granted a marketing authorisation in the European Union on
27 September 2017.[9]
The medicine is being jointly developed by Regeneron and Sanofi
under a global collaboration agreement.
Full summary of product characteristics for dupilumab can be
accessed at: https://www.medicines.org.uk/emc/product/8553/smpc
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
For more information please visit http://www.sanofi.co.uk.
References
1. NICE. Dupilumab for treating moderate to severe atopic
dermatitis [ID1048]. Available at:
https://www.nice.org.uk/guidance/gid-ta10218/documents/final-appraisal-determination-document
(Accessed June 2018).
2. NHS Choices. Atopic Eczema (Atopic Dermatitis). Available at:
https://www.nhs.uk/conditions/atopic-eczema/ (Accessed
June 2018).
3. Nutten S. Atopic Dermatitis: Global Epidemiology and Risk
Factors. Ann Nutr Metab 2015;66 (suppl 1): 8-16.
4. Office for National Statistics. 2014 UK mid-year population
estimate. Available at:
https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationprojections/bulletins/nationalpopulationprojections/2015-10-29
(Accessed June 2018).
5. Simpson et al. Patient burden of moderate to severe atopic
dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. Am Acad
Dermatol, pp. 74(3):491-498, 2016.
6. Sanofi. Data on File. August
2016.
7. Mount Sinai. Patient Care Atopic Dermatitis. Available at:
http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk.
(Accessed June 2018).
8. Simpson et al. Two Phase 3 Trials of Dupilumab versus Placebo
in Atopic Dermatitis. NEJM, vol. 375, pp. 2335-2348, 2016. SOLO 1:
Available at:
https://clinicaltrials.gov/ct2/show?term=solo&cond=Atopic+Dermatitis&rank=3.
(Accessed June 2018). SOLO 2:
https://clinicaltrials.gov/ct2/show?term=solo&cond=Atopic+Dermatitis&rank=2.
(Accessed June 2018).
9. European Medicines Agency. Dupilumab. Summary of Product
Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004390/WC500236507.pdf.
(Accessed June 2018).
SAGB.DUP.18.06.0836a Date of Preparation: June 2018