Janssen Announces Results of Phase 3 Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen of Rilpivirine And Cabotegravir through 96 Weeks

CORK, IRELAND, March 9, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson presented new data from the global Phase 3 trial today for the novel, investigational, long-acting (LA), two-drug injectable regimen – a combination of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir. The study – First Long-Acting Injectable Regimen (FLAIR) trial – demonstrated positive 96-week results in long-term safety and efficacy of rilpivirine and cabotegravir. These data were presented at the 2020 Conference on Retroviruses and Opportunistic Infections (CROI)“In our quest to make HIV history, we are encouraged by the safety and efficacy data of rilpivirine and cabotegravir at 96 weeks. Our work to improve the lives of people with HIV is centered around meeting the diverse needs of patients through developing new treatment options,” said Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health, Janssen Research &Development LLC. “We are excited that this long-acting injectable regimen could potentially provide a paradigm shift in managing the experience of living with HIV from daily to monthly dosing.”The global, pivotal, FLAIR Phase 3 study met its primary endpoint at Week 48 and the LA regimen continued to demonstrate non-inferiority to ViiV’s Triumeq® (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC), as measured by the proportion of patients with plasma HIV-1 RNA ≥50 copies per mil...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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RARITAN, NJ, May 13, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today updated results from the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ-4528, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in the treatment of patients with relapsed or refractory multiple myeloma. Longer-term follow-up results from the Phase 1b portion of the study (n=29), to be shared in an oral presentation at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program (Abstract #8505), show th...
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RARITAN, N.J., March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology’s 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.Click to ...
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