Innovative Medicine

Landmark approval is based on results from the Phase 3 AQUILA study, showing fixed-duration treatment with daratumumab significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring1 This milestone marks a critical advance in early intervention for multiple myeloma as the first authorised treatment, offering a new treatment paradigm for patients with high-risk smouldering disease2

Ibrutinib is the first approved Bruton’s tyrosine kinase (BTK) inhibitor to demonstrate statistically meaningful outcomes versus autologous stem cell transplant (ASCT) for the frontline treatment of transplant eligible patients with mantle cell lymphoma1 Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of care (SOC) with significantly improved overall survival and failure-free survival versus ASCT1

Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout combination of complete skin clearance, a favorable safety profile, and simplicity of a once daily pill

New Drug Application supported by results from the Phase 2b SunRISe-1 study

Accepted abstracts include discussion of novel embolization approach to treating migraine and microcatheter retention risks for liquid embolic agents

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy With the addition of CAPLYTA® to Johnson & Johnson’s robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults with schizophrenia

The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone or prednisolone compared to a current standard of care, abiraterone acetate plus prednisone or prednisolone1 The results demonstrate significant and clinically meaningful benefits of the niraparib and abiraterone acetate plus prednisone or prednisolone regimen in delaying cancer progression and worsening of symptoms1

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG IMAAVY, an FcRn blocker, received U.S. FDA approval earlier this year for the broadest population of individuals living with gMG, including anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older

If approved, daratumumab will be the first authorised treatment option for patients with smouldering multiple myeloma at high-risk of developing multiple myeloma, offering the potential for disease interception1 Recommendation backed by results from the Phase 3 AQUILA study, which demonstrate that daratumumab has the potential to significantly delay the onset of myeloma and the need for treatment, as well as to extend overall survival2