“People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” says Julie Block, President and Chief Executive Officer, National Eczema Association.
“To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That’s why today’s approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease.”
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 AD.
It comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose.
And it can be used with or without topical corticosteroids.
WHO IS DUPIXENT BEST SUITED FOR?
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. It is not known if Dupixent is safe and effective in children.
“Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases. In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease,” says George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron.
“Today’s approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program.”
Dupixent was evaluated by the FDA with Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions.
“We strive to transform scientific innovation into therapeutic solutions that make a meaningful difference to people’s lives,”says Olivier Brandicourt, M.D., CEO, Sanofi.
“The approval of Dupixent offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally.”
This follows the FDA’s 2014 Breakthrough Therapy designation for Dupixent for inadequately controlled moderate-to-severe AD.
Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs developed for serious or life-threatening conditions.
Dupixent represents the first time this designation was granted for a dermatological disease, other than in dermatologic cancers.
Sanofi Genzyme, the specialty care global business unit of Sanofi, and Regeneron will market Dupixent in the United States.
WHEN WILL IT BE AVAILABLE TO PATIENTS?
Dupixent is expected to be available to patients and providers in the U.S. later this week.
WHAT DOES IT COST?
The Wholesale Acquisition Cost (WAC) of Dupixent in the United States is $37,000 annually.
Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts, rebates or patient assistance programs.
Analysts say the drug could become a blockbuster therapy that could one day bring in more than $3 billion in annual sales.
SHOULD ANYONE NOT USE DUPIXENT AT ALL?
It should not be used in patients allergic to dupilumab or any of the ingredients in Dupixent.
WHAT ARE THE MOST COMMON SIDE EFFECTS TO USING DUPIXENT?
The most common adverse events that were noted to be greater than or equal to one percent with Dupixent treatment included injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips.
In December 2016, the European Medicines Agency accepted for review Sanofi’s and Regeneron’s marketing authorization application (MAA) for Dupixent for adults with uncontrolled moderate-to-severe AD.
ANY SERIOUS SIDE EFFECTS?
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.
WHEN SHOULD PEOPLE CONTACT A DOCTOR IF THEY EXPERIENCE SIDE EFFECTS?
People should tell their healthcare provider if they have any side effect that bothers them or that does not go away.
These are not all the possible side effects of Dupixent. Doctors can provide medical advice about side effects. They should also report side effects to FDA at 1-800-FDA-1088.
ANYTHING ELSE PEOPLE SHOULD KNOW?
- 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.
- Please click here for the full Prescribing Information.
- Patient information is available here.
ARE ANY ADDITIONAL STUDIES TAKING PLACE?
Dupilumab Program Overview
Dupilumab is currently being evaluated in a comprehensive development program for Atopic Dermatitis (AD) that includes studies in children with severe AD (6 months to 11 years of age) and adolescents with moderate-to-severe AD (12 to 17 years of age).
In October 2016, the FDA granted dupilumab Breakthrough Therapy designation for both populations. These potential uses are investigational and the safety and efficacy have not been evaluated nor confirmed by any regulatory authority.
Dupilumab is also being studied in other inflammatory diseases that are believed to be driven by IL-4 and IL-13 cytokines, including persistent uncontrolled asthma (Phase 3, results expected later this year), nasal polyposis (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.
WHERE CAN PEOPLE LEARN ABOUT CLINICAL TRIALS TAKING PLACE?
For more information on dupilumab clinical trials please visit www.clinicaltrials.gov.
IS THERE ANYONE THAT SHOULDN’T USE IT?
Do not use if you are allergic to dupilumab or to any of the ingredients in Dupixent®.
ANY OTHER SAFETY PRECAUTIONS PEOPLE SHOULD KNOW ABOUT?
People should tell their healthcare provider about their medical conditions BEFORE using Dupixent, including if they:
- 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 if 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.
ANYTHING ELSE PEOPLE SHOULD KNOW?
Sanofi and Regeneron recognize Dupixent can only help those uncontrolled moderate-to-severe AD patients prescribed the medicine if they can both access the medicine and use it properly.
Therefore, the companies have launched Dupixent MyWay™, a comprehensive and specialized program that provides support and services to patients throughout every step of the treatment process.
Dupixent MyWay™ will help eligible patients who are uninsured, lack coverage, or need assistance with their out-of-pocket costs.
Additionally, Dupixent MyWay™ offers personalized support from registered nurses and other specialists who are available 24/7 to speak with patients and help them navigate the complex insurance process.
For more information, please call 1-844-Dupixent (1-844-387-4936) or visit www.Dupixent.com
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 science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.