Innovative Medicine

Approval based on unprecedented Phase 3 data demonstrating statistically significant improvements in progression‑free survival and overall survival versus standard of care regimens 83.3% of patients were alive at three years, indicating durable clinical benefit

Fast Track designation reflects the unmet need in this serious disease and enables the potential for an accelerated FDA review timeline The designation is supported by a Phase 2 study in which nipocalimab demonstrated reduction in lupus disease activity and potential for steroid sparing Systemic lupus erythematosus is a debilitating, chronic autoantibody-driven disease affecting multiple organs, with limited treatment options and risk of irreversible organ damage Johnson & Johnson is actively enrolling patients in a Phase 3 study of adults with active systemic lupus erythematosus

Combination demonstrates deep PSA responses and favorable safety profile with plans to advance into Phase 3 Data highlight the potential of this first-in-class next-generation T-cell engager to expand the role of immunotherapy in prostate cancer

Data from the pivotal ENERGY trial showed IMAAVY® produced a rapid and durable hemoglobin responsea in wAIHA Currently no FDA-approved therapies are available for wAIHA, a rare, heterogeneous, life-threatening disease in which pathogenic immunoglobulin (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia

Subcutaneous (SC) amivantamab reduces administration from hours to minutes, with efficacy and safety consistent with intravenous (IV) amivantamab1,2,3,4,5 SC amivantamab is now authorised across all previously approved IV indications, offering fewer administration-related reactions and new dosing options1,2,3,4,5,6

More than 80% of those treated with TREMFYA® were in clinical remission and more than 50% were in endoscopic remission at Week 140 of the QUASAR long-term extension study, showing lasting disease control for patients 78% of patients achieved intestinal healing at both the tissue and visual level (histo-endoscopic mucosal improvement)

Ten percent complete response and rapid, durable antitumor activity reported with RYBREVANT FASPRO™; results surpass current standards of care

New designation is based on data showing rapid and durable responses in a heavily pretreated patient population and expands the promise of RYBREVANT FASPRO™ beyond lung cancer

Monthly dosing reduces treatment visits while maintaining established safety and efficacy1,2 Builds on RYBREVANT FASPRO™ FDA approval to deliver the simplest and fastest combination regimen for EGFR+ non-small cell lung cancer1,3-6