Johnson & Johnson Reports the EC’s Approval of Subcutaneous & Intravenous Tremfya for Active Crohn’s Disease

Shots: Approval was based on P-III trials, incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara; MAA of SC Tremfya for mod. to sev. UC under EMA’s review based…

ByRidhi RastogiMay 7, 2025

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Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya for Ulcerative Colitis (UC)

Shots: J&J has reported P-III (ASTRO) trial data assessing Tremfya SC induction (400mg at Wks. 0, 4 & 8) followed by either Tremfya 100mg SC Q8W or 200mg SC Q4W vs PBO in adults with mod. to sev. active UC; sBLA under the US FDA’s review At Wk. 24, trial showed improved clinical remission rates…

ByRidhi RastogiMay 6, 2025

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Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)

Shots: The US FDA has approved Imaavy to treat antibody +ve gMG pts (≥12yrs.) under priority review based on the ongoing P-III (Vivacity-MG3) trial assessing Imaavy + SoC vs PBO + SoC in antibody +ve or -ve adults (N=199; 153 were Ab +ve); global regulatory review is ongoing Trial showed superior disease control per MG-ADL…

ByDipanshu DixitMay 1, 2025

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Johnson & Johnson’s Tremfya Receives the EC’s Approval for Active Ulcerative Colitis (UC)

Shots: The EC has approved Tremfya to treat mod. to sev. active UC adults with inadequate response, no response or intolerance to SoCs or biologics; CHMP recommendation under EC review for mod. to sev. active Crohn’s disease with decision anticipated later 2025 Approval was based on P-IIb/III (QUASAR) trial assessing Tremfya (IV induction: 200mg Q4W;…

ByRidhi RastogiApril 25, 2025

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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

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Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

Shots: J&J has reported additional findings from P-III (Vivacity-MG3) trial & ongoing OLE assessing nipocalimab + SoC (30mg/kg, IV loading dose followed by 15mg/kg, Q2W) vs PBO in anti-AChR+, anti-MuSK+ & anti-LRP4+ adults (n=153) with gMG Trial showed a -4.9 QMG score improvement over 22 & 24wks. & pts were 4x more likely to sustain…

ByRidhi RastogiApril 10, 2025

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Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

Shots: The EC has approved label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT Approval was backed by P-III (PALOMA-3) trial, evaluating non-inferiority of…

ByRidhi RastogiApril 9, 2025

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Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America At 59mos. mFU, trial…

ByRidhi RastogiApril 8, 2025

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Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

Shots: J&J has reported P-IIIb (APEX) trial data assessing Tremfya vs PBO in biologic-naïve PsA pts with inadequate response to standard therapies for 24wks., followed by a 12wk. safety follow-up; eligible pts could enter a 2yr. extension phase prior to the final safety follow-up Trial met its 1EP of improved ACR20 response, showing reduced signs…

ByRidhi RastogiApril 7, 2025

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Johnson & Johnson Reports P-III (MARIPOSA) Trial Data of Rybrevant + Lazcluze for EGFRm NSCLC

Shots: J&J reported P-III (MARIPOSA) trial data assessing Rybrevant + Lazcluze vs osimertinib or Lazcluze alone as a 1L treatment of locally advanced or metastatic NSCLC pts (n=1074) with EGFR ex19del or L858R substitution mutations At 37.8mos. mFU, trial showed superior OS, with mOS not reached vs 36.7mos. for osimertinib-treated pts, plus 56% vs 44%…

ByRidhi RastogiApril 2, 2025

Johnson & Johnson Reports the EC’s Approval of Subcutaneous & Intravenous Tremfya for Active Crohn’s Disease

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya for Ulcerative Colitis (UC)

Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)

Johnson & Johnson’s Tremfya Receives the EC’s Approval for Active Ulcerative Colitis (UC)

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

Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

Johnson & Johnson Reports P-III (MARIPOSA) Trial Data of Rybrevant + Lazcluze for EGFRm NSCLC

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