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Janssen Announces Late-Breaking Data from Two Gene Therapy Programs at the American Academy of Ophthalmology 2022 Annual Meeting
Results from Phase 1/2 MGT009 study demonstrate safety profile of investigational gene therapy botaretigene sparoparvovec (AAV-RPGR) and suggest sustained vision improvement in patients with X-linked retinitis pigmentosa (XLRP) Data from a separate Phase 1 study show all three doses of investigational gene therapy JNJ-1887 met the primary endpoint for safety in adults with geographic atrophy (GA)
TREMFYA®▼ (guselkumab) Demonstrates Higher Rates of Complete Skin Clearance with Earlier Treatment in Adults with Moderate to Severe Plaque Psoriasis in Phase 3b GUIDE Study
GUIDE week 28 data demonstrate psoriasis patients treated with guselkumab ≤2 years after disease onset (versus >2 years) are more likely to achieve super-respondera status (complete skin clearanceb at week 20 through week 28) Late-breaking week 68 data suggest these super responders could maintain long-term disease control (low disease activity) with an extended dose interval
Final Analysis of Phase 2 GRIFFIN Study Presented for DARZALEX® (daratumumab)-based Investigational Quadruplet Regimen in Patients with Newly Diagnosed, Transplant-Eligible Multiple Myeloma
Data featured in plenary session at the 19th International Myeloma Society Annual Meeting
U.S. FDA Approves IMBRUVICA® (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease
IMBRUVICA® is now the only BTKi with 12 FDA approvals across seven indications, including five hematologic cancers and cGVHD
Janssen Marks First Approval Worldwide for TECVAYLI® (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma
Teclistamab, an off-the-shelf (ready to use) subcutaneously administered therapy, induced deep and rapid responses in triple-class exposed patients with relapsed and refractory multiple myeloma[1]
European Commission Approves IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
Approval marks the first all-oral, once-daily, fixed-duration Bruton’s tyrosine kinase (BTK) inhibitor-based regimen for first-line treatment of CLL
STELARA® (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis
As the first and only biologic targeting both cytokines interleukin (IL)-12 and IL-23, STELARA provides a new therapeutic option for children six years of age and older living with active psoriatic arthritis Active psoriatic arthritis in pediatric patients is a rare disease affecting five to eight percent of children and adolescents with chronic inflammatory arthritis*1-6
Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody TECVAYLI® (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM)
Teclistamab is the first T-cell redirecting bispecific antibody to receive a positive CHMP opinion for adults with RRMM and highlights Janssen’s commitment to innovation in multiple myeloma The opinion is based on the MajesTEC-1 study where teclistamab induced durable responses that deepened over time in patients with heavily pretreated RRMM[1]
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Novel GPRC5DxCD3 Bispecific Antibody Receives Breakthrough Therapy Designation Based Upon Results from the Phase 1/2 MonumenTAL-1 Study