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December 5, 2021

Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses

Preliminary Phase 2 study and a sub-study demonstrate value of mix-and-match approach; Johnson & Johnson booster increased neutralizing and binding antibodies, similar to boosting with BNT162b2, and showed strong increase in T-cell responses

Innovative Medicine

December 3, 2021

Latest Phase 3 Data for First-in-Class TREMFYA® (guselkumab) Demonstrates Significant and Durable Improvement in Signs and Symptoms of Active Psoriatic Arthritis while Maintaining its Safety Profile in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR)

The COSMOS study met its primary endpoint, with a significantly higher proportion of TREMFYA-treated patients (44.4 percent) versus placebo-treated patients (19.8 percent) achieving ACR20 response at week 24; the TREMFYA treatment effect in these TNFi-IR patients was seen by week four Response rates continued to improve at one year (week 48) with 57.7 percent of TREMFYA patients achieving ACR20 with a similar safety profile (week 56) TREMFYA is the first and only selective interleukin (IL)-23 inhibitor therapy approved in the U.S. for moderate to severe plaque psoriasis and active psoriatic arthritis irrespective of prior TNFi exposure

Innovative Medicine

November 30, 2021

Janssen Seeks Approval of IMBRUVICA®(ibrutinib) in a Fixed-Duration Regimen for Patients with Untreated Chronic Lymphocytic Leukaemia (CLL)

Application based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the safety and efficacy of an all-oral fixed-duration ibrutinib plus venetoclax combination regimen in adult patients with previously untreated CLL (1) (2)

Innovative Medicine

November 24, 2021

Johnson & Johnson COVID-19 Vaccine Fully Approved by Health Canada to Prevent COVID-19 in Individuals 18 years and Older

Vaccine demonstrates protection against COVID-19 related hospitalization and death, and across different variants

Innovative Medicine

November 17, 2021

Janssen Reports Positive Topline Week 48 Phase 2 Results for TREMFYA® (guselkumab) in Adults With Moderately to Severely Active Crohn’s Disease

The Phase 3 GALAXI 2 and 3 studies are continuing to enroll

Innovative Medicine

November 15, 2021

Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses

Milvexian demonstrated efficacy and no increase in bleeding across doses with no major bleeds in the milvexian arms, when compared with enoxaparin, for postoperative venous thromboembolism (VTE) prevention in patients undergoing elective total knee replacement (TKR) surgery AXIOMATIC-TKR is the first of two studies to read out from the Phase 2 milvexian program, which together will inform the design and dose regimens of the Phase 3 program Data simultaneously published in The New England Journal of Medicine and presented at the American Heart Association Scientific Sessions 2021 Milvexian is being developed by The Bristol Myers Squibb-Janssen Collaboration

Innovative Medicine

November 5, 2021

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021

More than 80 abstracts will be presented, including data supporting Cilta-Cel, Teclistamab, Talquetamab, DARZALEX® (daratumumab) and IMBRUVICA® (ibrutinib) Additional data for XARELTO® (rivaroxaban), Nipocalimab and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to highlight Janssen’s research in other hematologic diseases

Innovative Medicine

November 1, 2021

New Comprehensive Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Provided Durable Improvements in Measures of Psoriatic Arthritis (PsA) Disease Activity Through Two Years

TREMFYA, the first and only selective interleukin (IL)-23 inhibitor therapy approved in the U.S. to treat both adults with active PsA and adults with moderate to severe plaque psoriasis (PsO), demonstrated low rates of structural damage progression and durable improvements in physical function at week 100 Approximately 80-90 percent of TREMFYA-treated patients who achieved improvements in joint signs and symptoms and low levels of disease activity at week 52 (ACR20/50 and MDA) maintained this response at week 100

Global health equity

October 29, 2021

Statement on Data Published in PLOS Medicine on Tolerability and Immune Response of Johnson & Johnson Ebola Vaccine Regimen in Adults Living with HIV

Innovative Medicine

October 25, 2021

New Analyses Suggest Favorable Results for STELARA® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis

STELARA when used as a first-line therapy was associated with longer time in clinical remission or clinical response, including the postponing of surgery, among adult patients with moderately to severely active ulcerative colitis compared with usage as a second- or third-line therapy in a modelled analysis Bio-naïve patients with moderately to severely active Crohn’s disease started on STELARA showed higher rates of persistence at one year compared to adalimumab in a retrospective real-world evidence study

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