First investigational targeted biologic in the European Union to receive positive CHMP opinion for atopic dermatitis
Paris, France and Tarrytown, N.Y. – July 21, 2017 – Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Dupixent® (dupilumab), recommending its approval in Europe for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
Atopic dermatitis, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.[i],[ii],[iii],[iv] Moderate-to-severe atopic dermatitis is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.[v] Itch is one of the most burdensome symptoms for patients and can be debilitating. In addition, people with moderate-to-severe atopic dermatitis experience a high level of disrupted sleep, and increased anxiety and depression symptoms due to their disease.[vi]
Dupixent 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.[vii] If approved, Dupixent will come in a pre-filled syringe for self-administration by a patient as a subcutaneous injection every other week after an initial loading dose.7 Dupixent can be used with or without topical corticosteroids.
The European Commission (EC) is expected to adopt a final decision on the Marketing Authorization Application (MAA) for Dupixent in the European Union in the coming months. The CHMP opinion is based on studies from the global LIBERTY atopic dermatitis clinical trial program, including SOLO 1, SOLO 2, SOLO-CONTINUE, CHRONOS and CAFÉ.[viii],[ix] These studies incorporated data from nearly 3,000 adult patients with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or immunosuppressant such as cyclosporine, or when those therapies were not advisable.
In the US, Dupixent is approved for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.[x]
[i] Schneider et al, AAAI 2013, Practice Parameter Update, page 296
[ii] Eichenfield et al, AAD 2014, Guidelines of Care for Atopic Dermatitis, page 118
[iii] Guideline to treatment, European Dermatology Forum.
http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-miscellaneous?download=36:guideline-treatment-of-atopic-eczema-atopic-dermatitis. Accessed December 23, 2016
[iv] Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis- all you can do from the outside. Page 19
[v] National Institutes of Health (NIH). Handout on Health: Atopic Dermatitis (A type of eczema) 2013.
http://www.niams.nih.gov/ Health_Info/Atopic_Dermatitis/default.asp. Accessed October 31, 2016.
[vi] Simpson, E, Bieber, T and Eckert, L, “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.
[vii] Dupixent Summary of Product Characteristics.
[viii] Simpson et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. NEJM, vol. 375, pp. 2335-23348, 2016.
[ix] Blauvelt. A., Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. The Lancet, vol. 389, pp. 2287-2303, 2017.
[x] Dupixent Prescribing Information 2017. https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf. Accessed July 2017.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists for the past 30 years, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, and infectious and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its unique VelociSuite® technologies and ambitious initiatives such as The Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world.
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