DUPIXENT? (DUPILUMAB) SIGNIFICANTLY IMPROVED ITCH AND HIVES IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA, A STEP FORWARD IN DEMONSTRATING THE ROLE OF TYPE 2 INFLAMMATION IN THESE PATIENTS
Fifth disease in which Dupixent has demonstrated positive pivotal results
Phase 3 trial met primary and all key secondary endpoints at 24 weeks, showing Dupixent nearly doubled reduction in itch and urticaria activity scores
CSU results further demonstrate the potential of targeting IL-4 and IL-13 via IL-4Ra blockade to improve diseases with components of type 2 inflammation
Approximately 300,000 people in the?U.S.?have moderate-to-severe CSU that does not respond adequately to antihistamines alone
Data continue to support well-established safety profile of Dupixent
Regeneron Pharmaceuticals, Inc.?(NASDAQ: REGN) and Sanofi today announced a pivotal Phase 3 trial evaluating Dupixent??(dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-na?ve patients, compared to antihistamines alone in Study A, the first of two trials of the LIBERTY-CUPID clinical program.
"This is the first Phase 3 trial to show that by targeting IL-4 and IL-13, Dupixent can address the debilitating symptoms of chronic spontaneous urticaria like persistent itch and hives when standard-of-care antihistamines cannot sufficiently control the disease," said?George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "These data add to the increasing body of evidence that Dupixent can reduce the disease burden of a diverse range of dermatologic, respiratory and gastrointestinal diseases. By early 2022, we look forward to reporting results from a second trial in patients who were unable to control their chronic spontaneous urticaria with another biologic medicine, as well as other trial results in additional dermatologic diseases."
CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and feet, and can also affect the throat and upper airways. CSU is typically treated with antihistamines but the disease remains uncontrolled for up to 50% of patients who have limited available treatment options. CSU is the fifth disease for which Dupixent has positive Phase 3 data including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis (EoE, investigational).
"The chronic nature of CSU, coupled with intense itch, causes both a physical and emotional burden on people who have not found an effective treatment," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "This is the fifth inflammatory disease in which Dupixent has demonstrated a significant improvement in symptoms and disease manifestations in Phase 3 pivotal studies. The success of this trial underscores the agility of our clinical operations team considering the pandemic conditions and underscores our ability to deliver on an aggressive timeline for addressing a significant unmet need for this patient population."
In the trial (n=138), adding Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (placebo) with continuous improvement out to 24 weeks. Patients experienced a:
SOURCE?Regeneron Pharmaceuticals, Inc.
- 63% reduction in itch severity with Dupixent versus 35% with placebo, as measured by a 0-21 point itch severity scale (10.24 point reduction with Dupixent versus 6.01 point reduction with placebo, p<0.001), the primary endpoint in the?U.S.?(secondary endpoint in the EU).
- 65% reduction in urticaria activity (itch and hive) severity with Dupixent versus 37% with placebo, as measured by a 0-42 point urticaria activity scale (20.53 point reduction with Dupixent versus 12.00 point reduction with placebo, p<0.001), the primary endpoint in EU (secondary endpoint in the?U.S.).
- 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 Hannah Kwagh Tel: +1 914-847-6314 Hannah.Kwagh@regeneron.com | Investor Relations Vesna Tosic Tel: +1 914-847-5443 Vesna.Tosic@regeneron.com? |
Sanofi Contacts: | |
Media Relations Ashleigh Koss Tel: +1 908-205-2572 Ashleigh.Koss@sanofi.com | Investor Relations Sanofi Investor Relations ? Contacts Paris Eva Schaefer-Jansen Arnaud Delepine |
Sandrine Guendoul Tel: +33 (0)6 25 09 14 25 MR@sanofi.com | Sanofi Investor Relations ??Contacts North America Felix Lauscher Fara Berkowitz Suzanne Greco |
Media Relations Sally Bain Tel: +1 781-264-1091 Sally.Bain@sanofi.com | Sanofi IR main line: Tel: +33 (0)1 53 77 45 45 investor.relations@sanofi.com https://www.sanofi.com/en/investors/contact |