Full Press Release Details
FDA grants priority review for Dupixent (dupilumab) as potential
treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis
Paris and Tarrytown, NY November 6, 2018 The U.S. Food and Drug Administration (FDA) has accepted for Priority Review
the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate-to-severe atopic dermatitis. The target action date for the
FDA decision is March 11, 2019.
The sBLA is supported by data from a pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent
monotherapy in adolescent patients with moderate-to-severe atopic dermatitis, which were presented at the European Academy of Dermatology and Venereology in
Dupixent works by inhibiting interleukin-4 and
interleukin-13 (IL-4 and IL-13) signaling, which is one of the important contributors to Type 2 inflammation, a systemic response
known to play a role in moderate-to-severe atopic dermatitis.
currently approved in the U.S. as a treatment for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription
therapies or when those therapies are not advisable; and as add-on maintenance treatment for patients 12 years and older with
moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. In 2016, the FDA granted Breakthrough Therapy designation for
Dupixent for the treatment of moderate-to-severe (adolescents 12 to 17 years of age) and severe (children 6 months to 11 years of age) atopic dermatitis not well
controlled on topical prescription medications.
Dupixent is also approved for use in certain adult patients with moderate-to-severe atopic dermatitis in countries of the European Union, and other countries including Canada and Japan. In the U.S., more than 60,000 adult patients with atopic dermatitis have been
prescribed Dupixent to date.
The safety and efficacy of Dupixent in adolescents with atopic dermatitis have not been fully evaluated by any regulatory
Dupilumab ongoing development program
Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other Type 2
inflammation, including pediatric (6 months to 11 years of age) atopic dermatitis (Phase 3), pediatric
asthma (Phase 3), chronic rhinosinusitis with nasal polyps (Phase 3), eosinophilic esophagitis (Phase 3), grass allergy (Phase 2) and peanut allergy (Phase 2). A future trial is planned for
chronic obstructive pulmonary disease. Dupixent is also being studied in combination with REGN-3500, which targets IL-33. These potential uses are investigational and the safety and efficacy have not been
evaluated by any regulatory authority. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
SAFETY INFORMATION AND INDICATIONS
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT .
Before using DUPIXENT, tell your healthcare provider about all your medical conditions,
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. If you are taking asthma medicines, do not change or stop your asthma medicine without talking to your healthcare provider.
DUPIXENT can cause serious side effects, including:
The most common side effects include injection site reactions, pain in the throat (oropharyngeal
pain) and cold sores in your mouth or on your lips. Eye and eyelid inflammation, including redness, swelling and itching have been seen in patients who have atopic dermatitis.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. If your healthcare provider decides that you or a
caregiver can give DUPIXENT injections, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In
adolescents with asthma 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult.
accompanying full Prescribing Information including Patient Information.
DUPIXENT is a prescription medicine used:
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30
years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of
which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune which produces optimized fully-human antibodies, and ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
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please visit www.regeneron.com or follow @Regeneron on Twitter.
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