According to Regeneron Pharmaceuticals, the US Food and Drug Administration has approved Dupixent (dupilumab) as the first treatment for adults with pruritus nodular.
Prurigo nodularis, chronic, debilitating skin disease with type 2 primary inflammation, estimated to affect 75,000 US adults, and until now had no systemic treatment.
The approval was based on a first-line trial using two head-to-head phase 3 data tests evaluating the efficacy and safety of Dupixent. There are more in two processes sick people randomized to Dupixent, there was a clinically significant reduction in pruritus from baseline to both 12 weeks (44 and 37 percent, respectively, vs. 16 and 22 percent with placebo) and 24 weeks (60 and 58 percent, respectively, vs. 18 and 20 percent for placebo). Compared with placebo (18 and 16 percent), more than twice as many Dupixent patients (48 and 45 percent) achieved clear or nearly clear skin after 24 weeks. The safety profile was consistent with the use of Dupixent in other dermatologic conditions and included nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.
“Patients living with nodular pruritus are often faced with dozens, if not hundreds, of itchy and painful nodules covering their bodies,” George D. Yankopoulos, MD, Regeneron’s president and chief scientific officer, said in a statement. . “With this approval, those suffering from pruritus nodular finally have access to a medication to address the debilitating signs and symptoms of the disease.”
Dupixent Approval
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Citation: FDA Approves Dupixent for Prurigo Nodularis (October 3, 2022) Retrieved October 3, 2022, from https://medicalxpress.com/news/2022-10-fda-dupixent-prurigo-nodularis.html
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