FDA to Review DUPIXENT® (dupilumab) as Potential Treatment for Moderate-to-Severe Asthma
Published: Mar 02, 2018
TARRYTOWN, N.Y. and PARIS, March 2, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of DUPIXENT® (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma. Per the Prescription Drug User Fee Act, the target action date is October 20, 2018.
DUPIXENT is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two important signaling proteins (cytokines) that contribute to Type 2 inflammation in moderate-to-severe asthma.
The application is supported by clinical data from 2,888 adults and adolescents who participated in three pivotal trials from the LIBERTY ASTHMA clinical development program. Detailed results from the Phase 3 QUEST and VENTURE trials will be submitted for presentation at medical meetings later this year.
The potential use of DUPIXENT in asthma is currently under clinical development and the safety and efficacy for this use have not been fully evaluated by any regulatory authority.
In March 2017, the FDA approved DUPIXENT in the U.S. 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 is also approved for use in certain patients with moderate-to-severe atopic dermatitis in a number of other countries, including the countries of the European Union, Canada, and Japan.
About Moderate-to-Severe Asthma
People who live with moderate-to-severe asthma often experience decreased lung function and have severe attacks (exacerbations) that may lead to emergency room visits and hospitalizations. Despite currently available treatments, there remains an unmet need in patients who suffer from decreased lung function, severe exacerbations, long-term oral corticosteroid use and poor quality of life. Moderate-to-severe asthma is often associated with other Type 2 allergic inflammatory diseases. The disease is characterized by an imbalance or overactivity of certain immune cells and signaling proteins (including IL-4 and IL-13).
Dupilumab Development Program
Sanofi and Regeneron are studying dupilumab in a broad range of clinical development programs for diseases driven by Type 2 inflammation, including pediatric atopic dermatitis (Phase 3), nasal polyps (Phase 3) and eosinophilic esophagitis (Phase 2). These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab was discovered using Regeneron's proprietary VelocImmune® technology that yields optimized fully-human antibodies, and is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
For more information on dupilumab clinical trials please visit www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION AND INDICATION
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, including if you:
- have eye problems
- have a parasitic (helminth) infection
- have asthma
- are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. If you have asthma and 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:
- Allergic reactions. Stop using DUPIXENT and go to the nearest hospital emergency room if you get any of the following symptoms: fever, general ill feeling, swollen lymph nodes, hives, itching, joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
The most common side effects include injection site reactions, eye and eyelid inflammation, including redness, swelling and itching, and cold sores in your mouth or on your lips.
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 may report side effects to FDA at 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.
DUPIXENT is used to treat adult patients with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children. DUPIXENT is administered by subcutaneous injection at different injection sites every two weeks after an initial loading dose. DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after training in subcutaneous injection technique using the pre-filled syringe.