Tag Archives: Systemic Lupus Erythematosus

December, 2018

13 December
FDA Grants Fast Track Designation to Lilly’s Baricitinib for the Treatment of Systemic Lupus Erythematosus

INDIANAPOLIS, Dec. 13, 2018 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE). The Fast Track designation process aims to facilitate the development and …
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31 August
AstraZeneca’s Anifrolumab Fails to Meet the Primary Endpoint in its Phase 3 Trial in Systemic Lupus Erythematosus

AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE …
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20 July
Study Published in The Lancet Shows Benefit of Baricitinib for the Treatment of Systemic Lupus Erythematosus

INDIANAPOLIS, July 19, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that results of a global systemic lupus erythematosus (SLE) Phase 2 study for baricitinib were published by The Lancet. The study, the first completed Phase 2 study of a JAK inhibitor in SLE, showed that a statistically …
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24 July
GSK Receives FDA Approval for New Self-Injectable Formulation of Benlysta for Systemic Lupus Erythematosus

GSK announced today that the US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody‑positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus (SLE) is the most common form of lupus, a chronic, incurable autoimmune …
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14 June
Positive Phase 2a Safety and Efficacy Data Supports Further Development of Celgene’s Oral Lupus Drug

BOUDRY, Switzerland–(BUSINESS WIRE)–Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results from the phase 2a SLE-001 trial evaluating CC-220, the Company’s investigational, oral immunomodulatory compound, at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid. A trend toward greater improvement with CC-220 treatment compared …
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21 March
Lupus Study Shows Precision Medicine’s Potential to Define the Genetics of Autoimmune Disease

DALLAS – March 18, 2016 – Demonstrating the potential of precision medicine, an international study based at UT Southwestern Medical Center used next-generation DNA sequencing technology to identify more than 1,000 gene variants that affect susceptibility to systemic lupus erythematosus (SLE). Precision medicine is an emerging field that aims to deliver …
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11 November
AstraZeneca’s Lupus Drug Succeeds in Mid-Stage Study

AstraZeneca, along with its global biologics research and development arm, MedImmune, will present positive data today from the Phase II trial of anifrolumab for the treatment of moderate-to-severe systemic lupus erythematosus (SLE or lupus) at the American College of Rheumatology (ACR) 2015 Annual Scientific Meeting in San Francisco. Trial results …
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