Ebanga is a monoclonal antibody (mAb) with antiviral activity against Ebola virus disease provided through a single intravenous infusion. Monoclonal antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells. Ebanga is one of two therapeutics now licensed to treat patients infected with Ebola virus based on clinical trial data collected during an EVD outbreak in the Democratic Republic of Congo.
The Biomedical Advanced Research and Development Authority (BARDA) has awarded a 10-year contract to Emergent BioSolutions valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga (ansuvimab-zykl).
BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
The funding award consists of a base period of performance with two option periods for advanced development valued at approximately $121 million, and option periods for procurement of Ebanga™ treatment over five years valued at up to $583 million. If all option periods are exercised, the total contract value will be valued at up to approximately $704 million.
Under the terms of the contract, Emergent will complete activities to advance the development of Ebanga treatment through post-licensure commitments, including the transfer of technology as part of manufacturing scale-up, submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA), and completion of stability studies.
“For almost 25 years, Emergent has tackled the most serious diseases to assist governments in their preparedness and response strategies,” said Dr. Kelly Warfield, senior vice president, science and development at Emergent. “Ebola virus has the ability to emerge unexpectedly posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, which underscores the importance of preparedness efforts against this public health threat.”
Ebanga was developed for the treatment of Ebola by Ridgeback Biotherapeutics under a license from the National Institute of Allergy and Infectious Diseases (NIAID). Ridgeback Bio provided funding and operational support for clinical testing, with additional funding received from BARDA, for late-stage manufacturing and regulatory activities related to FDA approval of Ebanga treatment. Ebanga treatment was approved by the FDA in December 2020 for the treatment of Ebola.
In 2022, Emergent and Ridgeback Bio entered into a collaboration, whereby Emergent is responsible for the manufacturing, sale, and distribution of Ebanga treatment in the U.S. and Canada, and Ridgeback Bio serves as the Global Access Partner for Ebanga treatment, ensuring it remains available to patients in endemic countries free of charge through Ridgeback Bio’s compassionate use program. Ridgeback’s access program provides medical staffing and logistical support, in addition to free medicine, so that patients receive treatment in a timely way.
READ ALSO:
Ebanga™: The Most Recent FDA-Approved Drug for Treating Ebola.
This review provides a brief overview of the pharmacological effects and safety profile of ansuvimab in clinical trials and provides insights into the precise mechanism of this new drug for treating EVD. Ansuvimab is currently recognized as the most effective approved treatment option for EVD. Its efficacy in clinical trials has been promising compared to control treatments. However, further investigations are needed to assess the effects of this new mAb in different patients identified in outbreaks. There are still many questions about the effectiveness and safety profile of ansuvimab in vulnerable populations such as pregnant women, children and infants, and the elderly. Frontiers in Pharmacology – March 2023
There are only a few treatment options available for EVD to date, the most commonly used drugs for EVD are ZMapp, Inmazeb, and Ebanga. Results of this study showed Inmazeb is the preferred drug of choice over ZMapp or other drugs for the treatment of EVD, and Ebanga is a choice in patients with cardiovascular complications. In addition to that, supportive care is very essential to control the mortality rate. Journal of Infection and Public Health – March 2022
This article summarizes the milestones in the development of ansuvimab leading to this first approval for the treatment of infections caused by Ebola virus in adults and paediatric patients. Drugs – March 2021
FDA Approves Treatment for Ebola Virus
The U.S. Food and Drug Administration approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell.
During an Ebola outbreak in the Democratic Republic of the Congo (DRC) in 2018-2019, Ebanga was evaluated in a clinical trial (the PALM trial). The PALM trial was led by the U.S. National Institutes of Health and the DRC’s Institut National de Recherche Biomédicale with contributions from several other international organizations and agencies.
In the PALM trial, the safety and efficacy of Ebanga was evaluated in a multi-center, open-label, randomized controlled trial. 174 participants (120 adults and 54 pediatric patients) with confirmed Ebolavirus infection received Ebanga intravenously as a single 50 mg/kg infusion and 168 participants (135 adults and 33 pediatric patients) received an investigational control. The primary efficacy endpoint was 28-day mortality. The primary analysis population was all patients who were randomized and concurrently eligible to receive either Ebanga or the investigational control during the same time period of the trial. Of the 174 patients who received Ebanga, 35.1% died after 28 days, compared to 49.4% of the 168 patients who received a control.
Ebanga was granted an Orphan Drug designation, which provides incentives to assist and encourage drug development for rare diseases. Additionally, the agency granted Ebanga a Breakthrough Therapy designation. FDA – December 2020