Johnson & Johnson Innovative Medicine
Pharmaceutical Companies of Johnson and Johnson
European Commission approves TREMFYA (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease
TREMFYA (guselkumab) induction therapy administered either intravenously (GALAXI 2 and 3) or subcutaneously (GRAVITI) achieved the co-primary endpoints of clinical remissiona and endoscopic responseb at Week 12 compared to placebo Guselkumab demonstrated statistically significant and clinically meaningful improvements in clinical remissiona and endoscopic responseb at Week 48 compared to placebo in all three studies Data...
Johnson & Johnson submits application to the European Medicines Agency for additional subcutaneous RYBREVANT▼(amivantamab) dosing regimens to treat patients with EGFR-mutated advanced non-small cell lung cancer
Application supports every-three-week (Q3W) and every-four-week (Q4W) SC amivantamab dosing regimens Subcutaneous (SC) amivantamab offers patients greater convenience with reduced administration time from hours to minutes and lower rates of IRRs and associated symptoms compared to the intravenous (IV) formulation. 6 May 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company,...
Johnson & Johnson highlights new data, demonstrating long-term sustained disease control in adults living with generalised myasthenia gravis (gMG)
New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open label extension phase Up to 128 weeks and 180 patient years of follow-up in the open label extension phase demonstrates a safety profile consistent with the Phase 3 Vivacity-MG3 study 45%...
European Commission approves Johnson & Johnson’s subcutaneous DARZALEX (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility
Approval cements daratumumab as a foundational therapy in newly diagnosed multiple myeloma and the only anti-CD38 antibody for all patient types in this setting Phase 3 CEPHEUS study shows significant improvement in minimal residual disease (MRD)-negativity rate, progression-free survival and complete response or better versus standard of care. 7 April 2025 -- Beerse, Belgium -- Janssen-Cilag...
European Commission approves subcutaneous RYBREVANT▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Subcutaneous (SC) amivantamab offers patients greater convenience, reducing administration time from hours to minutes and with a five-fold reduction in infusion-related reactions compared to the IV formulation European Commission (EC) approval based on positive results from the Phase 3 PALOMA-3 study. 7 April 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced that...
TREMFYA (guselkumab) receives positive CHMP opinion for treatment of patients with moderately to severely active Crohn’s Disease
Recommendation based on the findings from the Phase 3 studies (GALAXI programme and GRAVITI) in Crohn’s disease 28 March 2025 -- Beerse, Belgium -- Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the Marketing Authorisation for TREMFYA® (guselkumab) to...
RYBREVANT (amivantamab) plus LAZCLUZE (lazertinib) demonstrates significant overall survival benefit in patients with EGFR-mutated advanced non-small cell lung cancer versus osimertinib
Median overall survival not yet reached with a projected improvement of more than one year versus osimertinib 26 March 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison...
Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis
Combination of complete skin clearance data and favourable safety profile in a once daily pill could shift treatment paradigm Nearly half of patients with moderate-to-severe plaque psoriasis (Pso) treated with investigational icotrokinra achieved completely clear skin (IGA 0) at Week 24 in ICONIC-LEAD Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary...
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous thromboembolic events CHMP has issued a positive opinion for an extension of marketing authorisation for subcutaneous amivantamab dosed every two weeks 3 February 2025 --...
European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care osimertinib Median overall survival improvement is expected to exceed one year. 21 January 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company,...
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