Shots:The EMA has received MAA of icotrokinra (QD) for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsOMAA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear…
Shots:The US FDA has received NDA of icotrokinra for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsONDA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear…
Shots:J&J has reported P-III (ICONIC-TOTAL) trial data assessing icotrokinra (QD, PO; n=208) vs PBO (n=103) in 311 PsO pts (≥12yrs.) with ≥1% body surface area & at least mod. plaque PsO at high-impact sitesAt Wk. 16, trial met its 1EP, with 57% vs 6% achieving IGA 0/1 & ≥2-grade improvement while in scalp…
Shots:J&J has reported subgroup analysis from P-III (ICONIC-LEAD) trial assessing icotrokinra (QD, PO; n=456) vs PBO (n=228) in 684 adolescents & adults with mod. to sev. plaque PsOAt Wk. 16, 84.1% adolescent achieved IGA 0/1 vs 27.3%, & 70.5% vs 13.6% reached PASI 90. By Wk. 24, 86.4% achieved IGA 0/1, 88.6% reached PASI…
Shots:Alumis & Kaken have partnered to develop, manufacture, & market ESK-001 for dermatology in Japan, with an option to expand into rheumatology & GI diseasesAs per the deal, Kaken will handle development, approval & marketing of ESK-001 in Japan in exchange for $40M upfront & near-term co-development costs, with ~$140M in milestones & field…
Shots:J&J has reported P-III trial data incl. ICONIC-LEAD (vs PBO) & ICONIC-ADVANCE 1&2 (vs Sotyktu) assessing icotrokinra (JNJ-2113, QD, PO) to treat mod. to sev. plaque Ps
OICONIC-LEAD showed that pts achieved IGA 0/1 (65% vs 8%) & reached PASI 90 (50% vs 4%) at 16wks. By Wk. 24, 74% achieved IGA 0/1,…
Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients The major highlights were the US FDA’s approval of Samsung Bioepis’ Epysqli for Treating Paroxysmal…

