Sanofi and Regeneron?S Dupixent Approves in the Eu as the First Targeted Medicine to Treat Young Children with Chronic Spontaneous Urticaria

Sanofi And Regeneron Enter Strategic Alliance For Dupixent In Chronic Spontaneous Urticaria. Dupixent also increased the percentage of patients with well-controlled disease and complete response at Week 24 compared with placebo. Safety results from Study A, Study C, and CUPIDKids were generally consistent with the known safety profile of Dupixent in its approved dermatological indications.

The most common adverse reactions for Dupixent overall are injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. Additional adverse reactions of injection site induration, injection site dermatitis, and injection site bruising or hematoma were reported in the CSU adult and adolescent studies. The adverse event more commonly observed with Dupixent (5%) than placebo in Study A and Study in adults and adolescents with CSU was COVID-19.

Safety data for children aged two to 11 years with CSU were generally consistent with the safety profile for adult and adolescent patients with CSU treated with Dupixent. In the US, the supplemental biologics license application for Dupixent has been accepted for review in certain children aged two to 11 years with CSU. Dupixent is currently approved for CSU in certain adults and adolescents in many jurisdictions, including the US and Japan.

The LIBERTY-CUPID phase 3 program evaluating Dupixent for CSU in children aged two to 11 years includes Study A, Study C, and CUPIDKids. CUPIDKids was a single arm clinical study that assessed the safety, efficacy, and pharmacokinetics of Dupixent in children aged two to 11 years with CSU who remained symptomatic despite the use of antihistamines. During the 24-week treatment period, Dupixent was administered at 200 mg every two (Q2W) or four weeks (Q4W) or 300 mg Q4W, with or without an initial loading dose, based on age and weight.

The primary endpoint measured the serum concentration of Dupixent over time, including C (lowest concentration before the next dose) at Week 12 and Week 24. Study A and Study C were replicate, double-blind, placebo-controlled clinical studies that assessed Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in patients aged six years and older who remained symptomatic despite the use of antihistamines and were naive to anti-IgE therapy. During the 24-week treatment period in both studies, all patients received an initial loading dose followed by either 300 mg Dupixent Q2W, or for pediatric patients weighing 30 kg to <60 kg, 200 mg Q2W.

In both studies, endpoints assessed at Week 24 included: Change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale) the primary endpoint; Change from baseline in itch (measured by the weekly itch severity score, 0-21 scale), the key secondary endpoint; Change from baseline in hives (measured by the weekly hive severity score, 0-21 scale), secondary endpoint; Proportion of patients achieving well-controlled disease status (UAS7 6); Proportion of patients with complete response (UAS7=0). Dupixent (dupilumab) is an injection administered under the skin (subcutaneous injection) at different injection sites. In children aged two to 11 years with CSU who remain symptomatic despite H1AH treatment, Dupixent is administered based on age and weight.

In children aged two to five years, Dupixent is administered at 200 mg Q4W for patients weighing 5 kg to <15 kg and 300 mg Q4W for 15 kg to <30 kg, without an initial loading dose. In children and adolescents aged six to 17 years, Dupixent is administered at 300 mg Q4W for 15 kg to <30 kg, 200 mg Q2W for 30 kg to <60kg, and 300mg Q2W for 60 kg, after an initial loading dose. In children aged two to 11 years, Dupixent should be administered by a caregiver if given at home.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, chronic obstructive pulmonary disease, bullous pemphigoid, and allergic fungal rhinosinusitis in different age populations.

More than 1,400,000 patients are being treated with Dupixent globally. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.