PIVOTAL DATA AT ATS 2021 SHOW DUPIXENT? (DUPILUMAB) SIGNIFICANTLY REDUCED ASTHMA ATTACKS AND IMPROVED LUNG FUNCTION IN CHILDREN
Regeneron Pharmaceuticals, Inc.?(NASDAQ: REGN) and Sanofi today announced that detailed results from a Phase 3 trial showed Dupixent??(dupilumab) significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation. Dupixent also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma, called fractional exhaled nitric oxide (FeNO). These data are being presented at the 2021?American Thoracic Society International Conference?(ATS 2021) and featured in the?Breaking News: Clinical Trial Results in Pulmonary Medicine?Scientific Symposium.
"Children living with uncontrolled moderate-to-severe asthma experience serious and persistent symptoms that can impact many crucial aspects of their lives including school, sleep and exercise," said?Leonard B. Bacharier, M.D., Professor of Pediatrics and Director of the?Center for Pediatric Asthma Research,?Monroe Carell Jr. Children's Hospital?at?Vanderbilt University Medical Center?in?Nashville, Tennessee?and principal investigator of the trial. "The trial results show that dupilumab, when added to standard-of-care therapy, significantly reduced asthma attacks, rapidly improved lung function and improved asthma control, which is especially important to these children during a particularly formative time in their lives."
Asthma is the most common chronic disease in children, with approximately 75,000 children aged 6 to 11 years living with the uncontrolled moderate-to-severe form of the disease in the?U.S., and many more worldwide. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. They also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Children who have asthma with underlying type 2 inflammation, which is the most common cause of asthma in children, are more likely to have poor asthma control, more frequent asthma attacks and symptoms that interfere with day-to-day activities.
The Phase 3, randomized, double-blind, placebo-controlled VOYAGE trial evaluated the efficacy and safety of Dupixent (100 mg or 200 mg every two weeks, based on weight) combined with standard-of-care asthma therapy?in 408 children with uncontrolled moderate-to-severe asthma. Two pre-specified populations with evidence of type 2 inflammation were evaluated for the primary analysis: 1) patients with baseline blood eosinophils (EOS) =300 cells/?l (n=259) and 2) patients with FeNO =20 parts per billion (ppb) or EOS =150 cells/?l (n=350).
Top line results from the trial, which met its primary and key secondary endpoints, were?announced?in?October 2020. These data showed that patients who added Dupixent to standard-of-care in these two patient groups, respectively, experienced:
- Substantially reduced rate of severe asthma attacks, with a 65% (p<0.0001) and 59% (p<0.0001) average reduction over one year compared to placebo (0.24 and 0.31 events per year for Dupixent vs. 0.67 and 0.75 for placebo, respectively).
- Improved lung function observed as early as two weeks and sustained for up to 52 weeks, measured by percent predicted FEV1?(FEV1pp).
- At 12 weeks, patients taking Dupixent improved their lung function by 5.32 and 5.21 percentage points vs. placebo (p=0.0036 and p=0.0009, respectively).
- This measure seeks to evaluate a patient's change in lung function compared to their predicted lung function based on age, height, sex and ethnicity to account for children's growing lung capacity at different stages of development.
- Significant improvement in asthma control at week 24 based on patient-reported disease symptoms and impact, measured on a 0-6 scale. On average, patients taking Dupixent improved their scores by 1.34 and 1.33 from baseline compared to 0.88 and 1.00 for placebo (average improvement of ?0.46 and -0.33 for Dupixent vs. placebo, p<0.0001 and p=0.0001, respectively). The improvement from baseline in patients taking Dupixent was more than double the clinically meaningful threshold of 0.5 points on the Asthma Control Questionnaire 7-Interviewer Administered (ACQ-7-IA).
- Significant reduction in mean?FeNO levels to below the threshold for type 2 inflammation, which is 20 parts per billion (ppb). Patients taking Dupixent had an average improvement in FeNO levels by -20.59 and -17.84 ppb vs. placebo from baseline to week 12 (p<0.0001 for both values).
- to treat people?aged 6 years and?older?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?6?years of?age.
- with other asthma?medicines?for the maintenance?treatment?of?moderate-to-severe eosinophilic or?oral?steroid?dependent?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.
- with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.
- have eye problems
- have a parasitic (helminth) infection
- 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.
- There is a pregnancy exposure registry for women who take DUPIXENT during pregnancy to collect information about the health of you and your baby. Your healthcare provider can enroll you or you may enroll yourself. To get more information about the registry call 1?877-311-8972 or go to?https://mothertobaby.org/ongoing-study/dupixent/.
- are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.
- 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. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
- Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. 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.
- Atopic dermatitis:?injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, and cold sores in your mouth or on your lips.
- Asthma:?injection site reactions, pain in the throat (oropharyngeal pain), and high count of a certain white blood cell (eosinophilia).
- Chronic rhinosinusitis with nasal polyposis:?injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, high count of a certain white blood cell (eosinophilia), trouble sleeping (insomnia), toothache, gastritis, and joint pain (arthralgia).
Regeneron Contacts: Media Relations Sharon Chen Tel: +1 914-847-1546 Sharon.Chen@regeneron.com | Investor Relations Mark Hudson Tel: +1 914-847-3482 Mark.Hudson@regeneron.com |
Sanofi Contacts: Media Relations Sally Bain Tel: +1 781-264-1091 Sally.Bain@sanofi.com | Investor Relations Sanofi Investor Relations ? Contacts Paris Eva Schaefer-Jansen Arnaud Delepine Sanofi Investor Relations ??Contacts North America Felix Lauscher Fara Berkowitz Suzanne Greco Sanofi IR main line: Tel: +33 (0)1 53 77 45 45 investor.relations@sanofi.com https://www.sanofi.com/en/investors/contact |