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Neuroscience

Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression

July 22, 2024

United States

Immunology

Johnson & Johnson strengthens pipeline to lead in atopic dermatitis with acquisition of Yellow Jersey Therapeutics

NM26 is a Phase 2-ready, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD)

The Company is leveraging a multi-pathway approach to transform treatment in atopic dermatitis and other immune-mediated diseases

July 11, 2024

United States

Immunology

Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class

First-and-only FcRn blocker to demonstrate superiority in activities of daily living (MG-ADL^a) over placebo when added to standard of care over 24 weeks in antibody positive patients: anti-AChR+, anti-MuSK+, anti-LRP4+

June 28, 2024

Oncology

CHMP adopts positive opinion for BALVERSA^® (erdafitinib) for the treatment of adult patients

Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers¹

The CHMP’s recommendation is based on results from Cohort 1 of the Phase 3 THOR study, which showed a 36 percent reduction in the risk of death with erdafitinib versus chemotherapy²

June 28, 2024

Immunology

Johnson & Johnson spotlights nipocalimab at FMF Congress 2024 – the first and only FcRn blocker to be studied in maternal fetal diseases

The Phase 3 AZALEA and Phase 3 FREESIA clinical studies are enrolling pregnant individuals who are at risk for severe HDFN and FNAIT

These rare and potentially life-threatening alloantibody diseases affecting pregnant individuals and their fetus or newborn currently have no approved treatments

June 24, 2024

Immunology

Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA^®(guselkumab) for the treatment of moderately to severely active Crohn’s disease

Submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs

TREMFYA^® is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) induction, and has the potential to be the first in its class to offer the option of both SC and IV induction therapy in Crohn’s disease

GALAXI includes data demonstrating superior outcomes for TREMFYA^® versus STELARA^® (ustekinumab) in Crohn’s disease

June 21, 2024

Immunology

TREMFYA^® (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction

TREMFYA^® Phase 3 Crohn’s disease study achieves all primary and secondary endpoints

June 20, 2024

Oncology

Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer

Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five-minute administration of subcutaneous amivantamab

Longer overall survival, progression-free survival and duration of response also observed with subcutaneous amivantamab

June 17, 2024

Immunology

Late-breaking results show nipocalimab significantly improves Sjögren’s disease activity in a Phase 2 study

Patients who received nipocalimab 15 mg/kg demonstrated a greater than 70 percent relative average improvement on the primary endpoint compared to patients who received placebo

Sjögren’s disease is a chronic, debilitating, and prevalent autoantibody disease with no approved advanced treatments

June 15, 2024

Oncology

TALVEY^® (talquetamab-tgvs) demonstrates highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma

24-month overall survival rate of 67 percent achieved with TALVEY^® 0.8 mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 study

June 14, 2024

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