Johnson & Johnson Reports the US FDA Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has approved Icotyde for the treatment of pts (≥12yrs., ≥40kg) with mod. to sev. plaque PsO who are candidates for systemic therapy or phototherapy Approval was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where Icotyde met all 1EP across all 4 trials (n=2,500). In the head-to-head studies, ~70% pts achieved IGA…

ByRidhi RastogiMarch 19, 2026

NEWS

BMS’ Sotyktu (Deucravacitinib) Wins FDA Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Shots: FDA approved Sotyktu(6mg, PO, QD) for adults with active PsA based on 2 P-III trials against PBO, with POETYK PsA-1 involving 670 bDMARD-naïve pts while POETYK PsA-2 involved 624 pts who were bDMARD-naïve & treated with prior TNFα inhibitor POETYK PsA-1 showed that 54% pts achieved ACR20 compared to 34%, while 24% vs 14%…

ByRidhi RastogiMarch 9, 2026

NEWS

Johnson & Johnson Reports the EMA’s MAA Submission of Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The EMA has received MAA of icotrokinra (QD) for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO MAA 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…

ByRidhi RastogiSeptember 12, 2025

TOP 20

Top 20 Immunology Companies of 2025

Shots: Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…

ByPrince GiriJuly 24, 2025

NEWS

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has received NDA of icotrokinra for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO NDA 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…

ByRidhi RastogiJuly 22, 2025

NEWS

Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis

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 sites At Wk. 16, trial met its 1EP, with 57% vs 6% achieving IGA 0/1 & ≥2-grade improvement while in scalp…

ByRidhi RastogiMay 12, 2025

NEWS

Johnson & Johnson Reveals P-III (ICONIC-LEAD) Trial Data of Icotrokinra for Plaque Psoriasis

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 PsO At 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…

ByRidhi RastogiApril 11, 2025

NEWS

Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

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,…

ByRidhi RastogiMarch 10, 2025

VIEWPOINTS

Daniel Quirk, SVP, Head of US Medical Affairs at Bristol Meyers Squibb Shares his Views on the US FDA Approval of Sotyktu

Shots: Daniel started the discussion by speaking about the epidemiology of plaque and briefed about SOTYKTU approved for the treatment of moderate-to-severe Plaque Psoriasis He also elaborated on the results from the P-III registrational studies POETYK PSO-1 and POETYK PSO-2 The interview also talks about how BMS is advancing its product portfolio to deliver innovative…

BySenior EditorApril 17, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in January 2023

Shots: The EMA approved 3 New Chemical Entity (NCE) and 5 Biologic Drugs in January 2023, leading to treatments for patients and advances in the healthcare industry In January 2023, the major highlights drugs were Xofluza’s Approval for influenza, Dupixent for eosinophilic esophagitis PharmaShots has compiled a list of a total of 8 new drugs…

BySenior EditorFebruary 23, 2023

Johnson & Johnson Reports the US FDA Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

BMS’ Sotyktu (Deucravacitinib) Wins FDA Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Johnson & Johnson Reports the EMA’s MAA Submission of Icotrokinra to Treat Plaque Psoriasis (PsO)

Top 20 Immunology Companies of 2025

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis

Johnson & Johnson Reveals P-III (ICONIC-LEAD) Trial Data of Icotrokinra for Plaque Psoriasis

Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

Daniel Quirk, SVP, Head of US Medical Affairs at Bristol Meyers Squibb Shares his Views on the US FDA Approval of Sotyktu

Insights+: EMA Marketing Authorization of New Drugs in January 2023

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