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June 23, 2021

Janssen Submits New Drug Application to U.S. FDA for XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

Application seeks two pediatric indications, including an age-appropriate new weight-based oral suspension formulation to help minimize dosing errors If approved, XARELTO® will be the first and only oral Factor Xa inhibitor indicated in the U.S. for use in appropriate pediatric patients

Innovative Medicine

June 12, 2021

New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia

GLOW study presented as a late-breaking abstract at the European Hematology Association (EHA) Virtual Congress

Innovative Medicine

June 12, 2021

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible

After nearly five years of follow-up, median progression-free survival was not reached, and a significant overall survival benefit was observed; data will be presented as a late-breaking abstract at the European Hematology Association (EHA) Virtual Congress

Global health equity

June 4, 2021

Statement on the SAGE Recommendation Regarding the Johnson & Johnson Ebola Vaccine Regimen

Innovative Medicine

June 2, 2021

New Phase 3b Psoriatic Arthritis (PsA) Data Show First-in-Class TREMFYA® (guselkumab) Achieved Robust Joint Symptom Improvement and Complete Skin Clearance in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR)

57.7 percent achieved ≥20 percent improvement in joint symptoms (ACR20) and 53.4 percent achieved complete skin clearance (PASI 100) at one year in COSMOS, the first study of a selective interleukin (IL)-23 inhibitor in a true TNFi-IR patient population Of 34 Janssen abstracts at the European League Against Rheumatism (EULAR) E-Congress, many present efficacy and safety data for TREMFYA in treating adults with active PsA

Innovative Medicine

June 1, 2021

Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs

- Clinical Data from More Than 10 Approved and Investigational Treatments for Solid Tumors and Hematologic Malignancies to be Presented During the 2021 ASCO Annual Meeting - Multiple Myeloma and Chronic Lymphocytic Leukemia Data to be Featured During EHA 2021 Virtual Congress

Innovative Medicine

June 1, 2021

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma

U.S. Milestone Follows European Medicines Agency PRIME Designation for this BCMA Bispecific Antibody for the Treatment of Relapsed or Refractory Multiple Myeloma

Innovative Medicine

June 1, 2021

Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma

Eighteen-month follow-up from pivotal CARTITUDE-1 study, including progression-free-survival data, to be presented at ASCO and EHA Annual Meetings Findings from the Phase 2 CARTITUDE-2 study will be presented for the first time

Innovative Medicine

May 26, 2021

Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

Further analysis from the Phase 3 ANDROMEDA study presented at the 2021 ASCO Annual Meeting also show doubling rates of organ response with no new safety signals for the first FDA-approved treatment in a rare blood cell disorder

Innovative Medicine

May 24, 2021

Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma

Results from Phase 1 study of novel GPRC5DxCD3 T-cell redirecting bispecific antibody demonstrate promising clinical activity and support recommended Phase 2 dose

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