Pharmaceuticals
Pharmaceuticals
Johnson & Johnson’s nipocalimab granted U.S. FDA Fast Track designation to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults
FNAIT is a rare disease that occurs when a pregnant person’s immune system attacks fetal platelets, resulting in the risk of internal bleeding, which can be life threatening to the fetus or newborn The Phase 3 FREESIA program is underway and nipocalimab is the only investigational therapy currently reported to be in clinical development for the treatment of FNAIT
U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)
OPSYNVI® combines two proven treatments with established efficacy and safety profiles into one tablet to be taken once daily, offering an option that helps to support the implementation of clinical guideline recommendations for early use of combination therapy.1 The comprehensive PAH portfolio at Johnson & Johnson now includes treatments that address all three foundational and guideline-recommended pathways for this rare, progressive disease.2 Approval is based on the results from the pivotal Phase 3 A DUE study, which met its co-primary endpoints, demonstrating significant pulmonary hemodynamic improvement.1
U.S. FDA Approves EDURANT® PED (rilpivirine) for Certain Pediatric Patients Living with HIV-1
This approval offers a new HIV-1 treatment option for children in the U.S. at least 2 years of age, weighing 14 kg – 25 kg and living with HIV
RYBREVANT® (amivantamab-vmjw) data at ELCC advance Johnson & Johnson’s ambition to transform the standard of care for patients with EGFR-mutated non-small cell lung cancer
Featured data include new results from the Phase 3 MARIPOSA study, which has received U.S. FDA Priority Review, and the Phase 1b PALOMA study of subcutaneous amivantamab
U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma
FDA ODAC unanimously votes 11 to 0 supporting favorable risk-benefit assessment of CARVYKTI® based on results from the Phase 3 CARTITUDE-4 study
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 Completes Acquisition of Ambrx
Acquisition strengthens Johnson & Johnson’s commitment to innovation in prostate cancer and deepens pipeline of next-generation antibody drug conjugates and targeted oncologic therapeutics
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