FDA provisionally approves Bryhali for treatment of plaque-type psoriasis in adult patients

recently, Bausch Health(and its dermatology company, Ortho Dermatologics) jointly announced that the U.SFDA(provisionally approved Brybetasol propionate, 0.01%) emulsion as a local treatmentdrug(for the treatment of plaque-shaped psoriasis in adult patients)final FDA approval will depend on a relatedproduct(after the expiration of the exclusive period, expected in early November 2018)With final approval, the company plans to bring Bryhali emulsionto to market as scheduled in November 2018Bryhali emulsionBryhali emulsion is a new type of powerful corticosteroid hormone drug that contains 0.01% halogenbutibutiproflocinin in the innovative excipient lotionThe safety of Bryhali emulsions has been confirmed in clinical studies, with patients treated with a daily local drug for 8 weeks, showing good tolerance and no increase in epidermis atrophyrelated studiesBryhali emulsion approval is based on data from two prospective, multicenter, randomized double-blind studiesThe study enrolled a total of 430 adult patients aged 18 and over with moderate to severe plaque-type psoriasis2 studies, 37% and 38% of patients in the Bryhali treatment group were successful in treatment (IGA improved at least 2 levels relative to baseline, IGA scored 0 (clear) or 1 (almost clear), and after 8 weeks of treatment there was no increase in skin atrophy, compared with 8% and 12% of patients in the extostrophic group, respectively In addition, two studies showed significant therapeutic success in the second and fourth weeks of topical use of Bryhali emulsions in the second and fourth weeks of topical use and continued to 12 weeks (4 weeks after treatment) safety
the most common adverse reactions observed in patients with Bryhali medication for 8 weeks were upper respiratory tract infections (2%), drug site dermatitis (1%) and high blood sugar (1%) Reversible hypothalamus-pituitary-adrenal (HPA) axial suppression was observed in the study, and the likelihood of glucocorticoid deficiency may occur during or after treatment of Bryhali emulsion