\n
\n <\/p>\n\n Please provide your email address to receive an email when new articles are posted on
.<\/p><\/div>\n<\/p><\/div>\n “
We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong> <\/p>\nBack to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways: <\/h2>\n\nApproval of dupilumab was extended to include children aged 2 to 11 years with chronic spontaneous urticaria.<\/li>\n The approval was supported by data from the LIBERTY-CUPID clinical trial program. <\/li>\n<\/ul>\nThe FDA approved dupilumab to treat children aged 2 to 11 years with chronic spontaneous urticaria and persistent symptoms despite H1 antihistamine treatment, according to a company press release. <\/p>\n
The FDA\u2019s decision expands the April 2025 approval of dupilumab (Dupixent, Regeneron\/Sanofi) for chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older. <\/p>\n
\n
\u201cBefore this approval, only antihistamines were approved for children younger than 12 years of age. Since about 50% of patients do not adequately respond to antihistamines alone, this leads to a gap in the treatment of [these] children,\u201d Thomas B. Casale, MD, <\/b>professor of medicine and pediatrics at University of South Florida in Tampa and an investigator for the LIBERTY-CUPID clinical trial program, told Healio.\u00a0\u201cBecause CSU is associated with decreased quality of life, anxiety and more, providing a therapeutic option for children with antihistamine unresponsiveness is a much-needed addition to our therapeutic armamentarium.\u201d<\/p>\n
As Healio previously reported, CSU affects approximately 1.7 million people in the United States and is characterized by red, swollen and itchy hives that are unpredictable, recur for 6 weeks or more and do not have an identifiable cause. <\/p>\n
<\/p>\n
Alyssa Johnsen<\/strong><\/p>\n<\/div>\n\u201cDupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits [interleukin]-4 and IL-13 signaling, two key and central drivers of the type 2 inflammation that contributes to this disease,\u201d Alyssa Johnsen, MD, PhD<\/b>, global therapeutic area head of immunology development at Sanofi, said in the release.<\/p>\n
The new approval was primarily supported by data from the LIBERTY-CUPID clinical study program, including two phase 3 studies, Study A and Study C, that included adults and adolescents aged 12 years and older with CSU, as well as pharmacokinetics data from the phase 3 CUPIDKids study that included children aged 2 to 11 years with CSU. <\/p>\n
For 24 weeks, participants in Study A and Study C were assigned dupilumab 200 mg every 2 or 4 weeks or 300 mg every 4 weeks based on weight and age. At the end of Study A, dupilumab had reduced itch severity by 63% and urticaria activity by 65% (P <\/i>< .001). In contrast, placebo reduced itch by 35% and urticaria activity by 37%, according to the release. <\/p>\n
Additional findings from Study C showed a higher proportion of participants assigned dupilumab compared with placebo achieved well-controlled disease status (41% vs. 23%; P <\/i>= .005) and complete response (30% vs. 18%; P <\/i>= .02), according to the release. <\/p>\n
In addition, Study B in the LIBERTY-CUPID program showed dupilumab\u2019s safety profile was consistent with its known safety profile in its approved dermatologic indications. The most common adverse event was injection site reactions, occurring in 2% or more participants. Investigators did not observe any new safety events in children aged 2 to 11 years, according to the release. <\/p>\n
\u201cDupixent is now approved for nine different allergy-related conditions, from asthma to atopic dermatitis, and this is the fifth of these indications now extended to young children,\u201d George D. <\/b>Yancopoulos<\/b>, MD, PhD, <\/b>board co-chair, president and chief scientific officer at Regeneron, said in the release.<\/p>\nFor more information:<\/h2>\n
Thomas B. Casale, MD, can be reached at tbcasale@usf.edu.<\/p>\n
\n
\n
Sources\/Disclosures<\/h3>\n Source: <\/h2>\n
References:<\/h2>\n\n
Disclosures: <\/strong>
<\/p>\n
\n
\n
<\/p>\n
Ask a clinical question<\/strong> and tap into Healio AI’s knowledge<\/strong> base.<\/p>\n
<\/p>\nPubMed, enrolling\/recruiting trials, guidelines<\/li>\n
<\/p>\n
Clinical Guidance, Healio CME, FDA news<\/li>\n
<\/p>\n
Healio’s exclusive daily news coverage of clinical data<\/li>\n
\n <\/ul>\n
Learn more<\/button>\n <\/div>\n<\/div>\n