Safety data over the 16-week treatment period showed:Additional prespecified AEs across all weight groups and doses included skin infections (6% for Dupixent every four weeks, 8% for Dupixent every two weeks, and 13% for TCS alone), which is noteworthy because patients with atopic dermatitis have an increased risk of skin infections. To submit a request online, please visit UPMC's PromptPA Portal. In adult atopic dermatitis trials, the incidence of serious skin infections was 57% less with Dupixent compared to the control groups. Across all approved indications globally, more than 170,000 patients have been treated with Dupixent.The Phase 3, multicenter, open-label extension trial evaluated long-term safety and efficacy of Dupixent treatment in 2,282 adults and adolescents with moderate-to-severe asthma who had previously participated in a controlled Dupixent clinical trial, including the pivotal Phase 2b DRI (24 weeks) and Phase 3 QUEST (52 weeks) trials in patients with moderate-to-severe asthma and the Phase 3 VENTURE (24 weeks) trial in patients with severe oral corticosteroid (OCS)-dependent asthma. ; To submit a request via fax, please select the appropriate form below. In addition, in the pediatric trial (6-11 years of age), herpes viral infections occurred in 0% of Dupixent patients every four weeks, 2% of Dupixent patients every two weeks, and 5% for patients on TCS alone.Dupixent has been studied in more than 8,000 patients ages 6 years and older across more than 40 clinical trials. Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or … The primary endpoints were the number and proportion of patients experiencing any AEs up to 96 weeks. Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; and have atopic dermatitis or CRSwNP, and also have asthma. The Breakthrough Therapy designation was created to expedite the development and review of drugs developed for serious or life-threatening conditions.Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that often appears as a rash on the skin. Patients in the open-label extension trial received 300 mg Dupixent every other week for up to 96 weeks in addition to standard-of-care maintenance therapies. Dupixent (dupilumab) PA: BIOLOGICAL: Duraclon (clonidine injection) ANALGESICS # Duragesic (fentanyl 75, 100 mcg/hr transdermal system) PA: OPIOID ANALGESICS: Duragesic (fentanyl 12, 25, 50 mcg/hr transdermal system) PA > 50 mcg/hr and PA > 10 patches/month: OPIOID ANALGESICS # Data from Dupixent clinical trials have shown that IL … In adolescents 12 years of age or older, it is recommended that Dupixent be administered by or under the supervision of an adult.Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including the EU and Dupilumab was invented using Regeneron’s proprietary Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins and herbal supplements. Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Call your doctor for medical advice about side effects. Visit Use DUPIXENT exactly as prescribed. 210mg/1.5mL (single-dose prefilled syringe) Psoriasis. DUPIXENT is an injection given under the skin (subcutaneous injection). Adult Pediatric. Results showed:Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Additional long-term efficacy data in OCS-dependent patients will be presented at a later congress. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Patients entered the extension trial after finishing active treatment or placebo in the initial trials and were treated for up to an additional two years, providing up to three years of treatment data in total. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). The safety analyses included patients from all three pivotal asthma trials and the efficacy and biomarker analyses included patients who are not dependent on oral corticosteroids (OCS) from the pivotal Phase 2b and Phase 3 QUEST trials. Across all approved indications globally, more than 150,000 patients have been treated with Dupixent.“This FDA approval is another milestone in the journey for Dupixent as an innovative biologic treatment for atopic dermatitis and other conditions driven in part by type 2 inflammation,” said The FDA evaluated the Dupixent application under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.