Siltuximab

Atossa Therapeutics, Inc. Announces Appointment of Pharma Industry Veteran Richard Graydon, M.D., Ph.D.

Retrieved on: 
Tuesday, October 25, 2022

Dr. Graydon will devote all of his professional time to the Atossa clinical programs.

Key Points: 
  • Dr. Graydon will devote all of his professional time to the Atossa clinical programs.
  • Prior to joining Atossa, Dr. Graydon served as Senior Director of Clinical Development at Johnson and Johnson where he was responsible for leading compound development and clinical trial programs for Janssen Pharmaceuticals.
  • Dr. Graydon spent time in clinical practice following completion of his specialty training in hematology and oncology at Harvard Massachusetts General Hospital.
  • Dr. Graydon is the author of The Genetic Risks of Cancer: The Effects of DNA, Genomics and Inheritance on Aging and Survival.

BeiGene and EUSA Pharma Announce NMPA Approval of SYLVANT® (Siltuximab for Injection) in China for Idiopathic Multicentric Castleman Disease

Retrieved on: 
Friday, December 3, 2021

Siltuximab is a monoclonal antibody approved in the United States, European Union, and other countries and regions around the world.

Key Points: 
  • Siltuximab is a monoclonal antibody approved in the United States, European Union, and other countries and regions around the world.
  • This approval is our second product in our collaboration with EUSA, highlighting the combined expertise of our companies as we work together on behalf of patients.
  • Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease.
  • We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera.

BeiGene and EUSA Pharma Announce NMPA Approval of SYLVANT® (Siltuximab for Injection) in China for Idiopathic Multicentric Castleman Disease

Retrieved on: 
Friday, December 3, 2021

Todays approval provides a new treatment for patients in China with this rare systemic disorder, commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene.

Key Points: 
  • Todays approval provides a new treatment for patients in China with this rare systemic disorder, commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene.
  • This approval is our second product in our collaboration with EUSA, highlighting the combined expertise of our companies as we work together on behalf of patients.
  • Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease.
  • We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera.

SYLVANT® (siltuximab) Recommended by the National Comprehensive Cancer Network® (NCCN®) as the Preferred Treatment Option for Patients with Idiopathic Multicentric Castleman Disease (iMCD) regardless of histopathologic subtype

Retrieved on: 
Thursday, February 25, 2021

As the only FDA-approved therapy indicated for this patient population, the change in the NCCN Guidelines means that even more patients will be able to benefit.

Key Points: 
  • As the only FDA-approved therapy indicated for this patient population, the change in the NCCN Guidelines means that even more patients will be able to benefit.
  • Siltuximab is a monoclonal antibody that directly neutralises IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions.
  • Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease.
  • Insufficient evidence exists to use histopathologic subtype to guide treatment of idiopathic multicentric Castleman disease, American Journal of Hematology.

EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for SYLVANT® (Siltuximab for Injection) in China

Retrieved on: 
Monday, January 25, 2021

EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that the Biologics License Application (BLA) for SYLVANT (siltuximab for injection) was accepted by the China National Medical Products Administration (NMPA) and granted priority review.

Key Points: 
  • EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that the Biologics License Application (BLA) for SYLVANT (siltuximab for injection) was accepted by the China National Medical Products Administration (NMPA) and granted priority review.
  • Siltuximab is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.
  • Lee Morley, Chief Executive Officer of EUSA Pharma, said, The BLA acceptance of siltuximab for review in China represents another exciting step in delivering therapies to patients in need worldwide.
  • We will continue in our close collaboration with BeiGene and the NMPA to potentially bring siltuximab to iMCD patients in China.

EUSA Pharma Announces First Patient Enrolled in a Randomised Phase 3 Clinical Trial Investigating Siltuximab in Hospitalised Patients with COVID-19- or Another Respiratory Virus Infection-Associated Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Thursday, December 17, 2020

The SILVAR study is a very important step to potentially confirm the encouraging results of the Italian observational cohort-control SISCO study in a prospective, randomised, controlled fashion.

Key Points: 
  • The SILVAR study is a very important step to potentially confirm the encouraging results of the Italian observational cohort-control SISCO study in a prospective, randomised, controlled fashion.
  • IL-6 signalling pathway inactivation with siltuximab in patients with COVID-19 respiratory failure: an observational cohort study.
  • The primary objective is to demonstrate a significant reduction in 28-day mortality with the addition of siltuximab to SOC.
  • Siltuximab is a monoclonal antibody that directly neutralises IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions.

EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Retrieved on: 
Thursday, July 2, 2020

We thank the FDA for recognizing the importance of this clinical trial and the quick approval we received.

Key Points: 
  • We thank the FDA for recognizing the importance of this clinical trial and the quick approval we received.
  • To date, several independent clinical trials have begun globally to explore the safety and efficacy of siltuximab for the treatment of severe COVID-19 patients.
  • EUSA Pharma has received FDA approval to proceed with a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated ARDS, compared to placebo plus standard of care.
  • 2 IL-6 Signalling Pathway Inactivation With Siltuximab in Patients With COVID-19 Respiratory Failure: an Observational Cohort Study.

EUSA Pharma and Papa Giovanni XXIII Hospital, Italy, Provide Interim Analysis Data for Siltuximab-Treated COVID-19 Patients from the SISCO Study

Retrieved on: 
Wednesday, April 1, 2020

Combined, this means that over three-quarters of patients treated with siltuximab (76%, n=16) had either stable or improved disease at this interim analysis.

Key Points: 
  • Combined, this means that over three-quarters of patients treated with siltuximab (76%, n=16) had either stable or improved disease at this interim analysis.
  • Further data will be made available on remaining patients, the case-control analysis and 30 day follow-up of mortality as they become available.
  • We are very grateful to the team at Papa Giovanni XXIII Hospital in Bergamo, Italy, for their extraordinary efforts to undertake the SISCO Study and collate these interim data under extremely difficult circumstances.
  • The study represents the data collection and analysis of a series of patients treated under an ongoing emergency compassionate use protocol.

EUSA Pharma and the Papa Giovanni XXIII Hospital, Bergamo, Italy Announce Initiation of an Observational Case-control Study of Siltuximab in Patients with COVID-19 who have Developed Serious Respiratory Complications

Retrieved on: 
Wednesday, March 18, 2020

Ergomed plc (LSE: ERGO), a company focused on providing specialized services to the pharmaceutical industry, is providing clinical research services for the study.

Key Points: 
  • Ergomed plc (LSE: ERGO), a company focused on providing specialized services to the pharmaceutical industry, is providing clinical research services for the study.
  • Lee Morley, Chief Executive Officer, EUSA Pharma, said: We are delighted to support this study to investigate the potential for siltuximab to help patients severely ill as a result of COVID-19.
  • Sponsored by the Papa Giovanni XXIII Hospital, the SISCO Study is an observational case-control trial of siltuximab, a chimeric monoclonal antibody targeting human interleukin (IL)-6, for the treatment of patients infected with COVID-19 who develop serious respiratory complications.
  • The study represents the data collection and analysis of a series of patients treated under an ongoing emergency compassionate use protocol.

EUSA Pharma and BeiGene Announce Exclusive Development and Commercialization Agreement for SYLVANT® and QARZIBA®▼ in Greater China

Retrieved on: 
Monday, January 13, 2020

and BEIJING, China, Jan. 13, 2020 (GLOBE NEWSWIRE) -- EUSA Pharma (EUSA) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that they have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT (siltuximab) and QARZIBA (dinutuximab beta) in Greater China.

Key Points: 
  • and BEIJING, China, Jan. 13, 2020 (GLOBE NEWSWIRE) -- EUSA Pharma (EUSA) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that they have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT (siltuximab) and QARZIBA (dinutuximab beta) in Greater China.
  • Under the terms of the agreement, EUSA has granted BeiGene exclusive rights to SYLVANT in Greater China and to QARZIBAin mainland China.
  • Under the agreement, BeiGene will fund and undertake all clinical development and regulatory submissions in the territories, and will launch and commercialize both products once approved.
  • BeiGene brings to our collaboration exceptional development and commercialization capabilities in China and a clear focus on delivering innovative, targeted oncology medicines.