Innovative Medicine
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Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of TREMFYA®(guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis
Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage of patients with moderately to severely active ulcerative colitis who received TREMFYA® achieved clinical remission at Week 44 compared with placebo -
New data shows JNJ-2113, the first and only investigational targeted oral peptide, maintained skin clearance in moderate-to-severe plaque psoriasis through one year
JNJ-2113 long-term extension FRONTIER 2 study demonstrated sustained efficacy from Week 16 to Week 52 and safety results consistent with previously reported data (FRONTIER 1 Study) in a late-breaking oral presentation at the American Academy of Dermatology 2024 Annual Meeting -
Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma
Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly reduced the risk of progression or death, compared to standard of care regimen.1 -
RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in patients with previously untreated NSCLC with EGFR exon 20 insertion mutations National Comprehensive Cancer Network ® (NCCN ®) updated its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) to recommend amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a preferred first-line regimen for patients with NSCLC with EGFR exon 20 insertion mutations -
Johnson & Johnson Announces Expansion of IMBRUVICA® (ibrutinib) Label in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications
IMBRUVICA® is now the only Bruton’s tyrosine kinase inhibitor (BTKi) approved with an oral suspension formulation, providing additional flexibility for patients who may have difficulty swallowing tablets or capsules -
Janssen Receives Positive CHMP Opinion for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma
Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the potential to offer significant benefit to patients in earlier lines of treatment1 Most patients with multiple myeloma relapse after current standard treatments and remain in need of additional therapeutic options at earlier stages of the disease1 -
TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma
Biweekly dosing with TECVAYLI®, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility -
Johnson & Johnson highlights innovation in hemolytic disease of the fetus and newborn (HDFN) at the Society for Maternal-Fetal Medicine’s (SMFM) 2024 Pregnancy Meeting
Presentations include additional analyses of nipocalimab data from pregnancies at risk for early-onset severe HDFN; Nipocalimab is the only anti-FcRn being studied in this rare and potentially life-threatening two-person disease for which there are no approved non-surgical therapies -
Johnson & Johnson’s nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN)
Breakthrough Therapy Designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for HDFN Phase 3 clinical trial enrollment underway, representing the only therapy reported to be under clinical development for this serious, life-threatening and rare condition