Shots:The US FDA has approved Yuflyma, a biosimilar version of Humira (adalimumab) & its unbranded version for the treatment of HS in adolescents (≥12yrs.), & uveitis in children (≥2yrs.)Yuflyma, an anti-TNFα mAb, was previously approved by the FDA for rheumatoid & psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, &…
Shots:The US FDA has approved Rhapsido for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Regulatory filings are also made in the EU, Japan & China, with priority review granted in ChinaApproval was backed by P-III (REMIX-1 & 2) trials in CSU, which showed improved…
Shots:Sanofi has reported the P-IIa (HS-OBTAIN) trial data assessing brivekimig (150mg, SC, Q2W) vs PBO in pts with mod. to sev. hidradenitis suppurativa, incl. biologic-naïve pts for 16 wks., followed by a 12wk. open-label period & an 8wk. safety follow-upAt 16wks., brivekimig achieved higher HiSCR50 median response rates of 67% vs 37%, with 54%…
Shots:The 2 P-III (STOP-HS1 & STOP-HS2) trials assessed povorcitinib (45 or 75mg, QD, PO) vs PBO in mod. to sev. HS pts (≥18yrs.; n=600 each) for 12wks., followed by 42wk. extension & 30-day follow-up
STOP-HS1 met its 1EP, with povorcitinib (45 mg/75 mg) showing higher HiSCR50 rates at Wk. 12 (40.2%/40.6% vs 29.7%), while…

