FDA Approves Asthma Indication for Dupixent® (dupilumab)
Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype
Only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype
Only asthma biologic that offers patient self-administration at home
Only asthma biologic also approved for adult patients with moderate-to-severe atopic dermatitis, a Type 2 inflammatory disease driven by the IL-4 and IL-13 pathway
In clinical trials, Dupixent reduced severe exacerbations and oral corticosteroid use and improved lung function
Dupixent inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to the Type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers including fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE) and eotaxin-3 (CCL26).
"Dupixent is now approved in the U.S. for two important groups of uncontrolled asthma patients – those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma," said
"Today's approval marks a significant development for certain people with moderate-to-severe asthma aged 12 years and older. For patients dependent on oral corticosteroids, Dupixent improved lung function, reduced oral corticosteroid use and reduced exacerbations regardless of baseline eosinophil levels," said
Patients with moderate-to-severe asthma often have uncontrolled, persistent symptoms despite standard-of-care therapy that may make them suitable for treatment with a biologic therapy. They live with coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks that may require emergency room visits or hospitalizations. Oral corticosteroids can provide relief for severe, short-term symptoms. However, their chronic use is limited to the most severe patients due to the potential for serious side effects.
"Despite being compliant with their current medicine, many people with moderate-to-severe asthma, including those with eosinophilic phenotype or with oral steroid dependence, live with persistent symptoms like unpredictable attacks and difficulty breathing," said
For people with asthma, Dupixent comes in two doses (200 mg and 300 mg) given every other week at different injection sites after an initial loading dose.
Efficacy and safety results from the Dupixent asthma pivotal clinical trial program
The pivotal trial program evaluated 2,888 adult and adolescent patients with moderate-to-severe asthma in three randomized, placebo-controlled, multicenter trials (Trial 1, Trial 2 and Trial 3) for six months to one year (24 to 52 weeks). All trials enrolled patients irrespective of minimum baseline eosinophil levels.
In Trial 2 (the largest trial), Dupixent reduced exacerbations and improved lung function in the overall population. Benefits in exacerbations were seen in patients with eosinophil counts greater than or equal to 150 cells/microliter, which represented 70% of the patients enrolled. Efficacy improved in patients with higher eosinophil counts. For example, in patients with blood eosinophils of 300 cells/microliter or greater, Dupixent reduced severe exacerbations by 67% compared to placebo, and improved FEV1 (lung function) by 29%-33% compared to 14%-16% for placebo. In patients with eosinophil counts less than 150 cells/microliter, there was no difference in severe exacerbation rates for Dupixent versus placebo.
In Trial 3, which evaluated severe, oral corticosteroid-dependent patients, Dupixent reduced average daily oral corticosteroid use by 70% compared to 42% with placebo. More than half of patients treated with Dupixent completely eliminated use of oral corticosteroids. Effects on lung function and on oral steroid and exacerbation reduction were similar for Dupixent irrespective of baseline blood eosinophil levels.
In the asthma clinical trials, the adverse reactions that occurred with Dupixent at a rate of at least 1% and more frequently than the respective comparator were injection site reactions, sore throat, and an increase in the number of eosinophils, a type of white blood cell, in the blood.
Additional data can be found in the prescribing information. Data from Trial 1 were published in The Lancet in
Dupixent comes in a pre-filled syringe and is intended for injection under the skin (subcutaneous injection) under the guidance of a healthcare provider. It can be given in a clinic or, for convenience, at home by self-administration after training by a healthcare professional.
Dupixent is also approved 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. In the U.S., Dupixent is marketed by Regeneron and Sanofi Genzyme, the specialty care global business unit of
The wholesale acquisition cost of Dupixent remains unchanged and will be the same for both asthma doses. Regeneron and
Dupixent is currently under regulatory review for moderate-to-severe asthma in several other countries, including
Dupilumab development program
For more information on dupilumab clinical trials please visit www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION
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 (if you also have atopic dermatitis)
- have a parasitic (helminth) infection
- are taking oral, topical, or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back.
- 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 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 (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: breathing problems, fever, general ill feeling, swollen lymph nodes, swelling of the face, mouth and tongue, hives, itching, fainting, dizziness, feeling lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. If you have atopic dermatitis, tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
- Inflammation in your blood vessels: Rarely, this can happen in people with asthma who receive DUPIXENT. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you have: rash, shortness of breath, persistent fever, chest pain, or a feeling of pins and needles or numbness of your arms or legs.
The most common side effects include injection site reaction, 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
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.
Please see accompanying full Prescribing Information including Patient Information.
DUPIXENT is a prescription medicine used:
- to treat adults 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 with atopic dermatitis under 18 years of age.
- with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age.
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.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
With more than 100,000 people in 100 countries,
Regeneron Forward-Looking Statements and Use of
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although
Tel: +1 (914) 847-5018
Manisha Narasimhan, Ph.D.
Tel: 1 (914) 847-5126
Tel: +1 (908) 981-8745
Tel: +33 (0)1 53 77 45 45