BARDA announces the 57th FDA Approval/Licensure/Clearance for Medical Countermeasures supported by BARDA under Novel Public Private Partnerships


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Over the last 14 years since BARDA was established, our team of experts and scientists have collaborated with more than 300 industry partners to support development and manufacturing of a diverse portfolio of medical countermeasures needed to address national security and public health threats.

From investing in early innovation, to late stage development through U.S. Food and Drug Administration (FDA) approval, with each partnership, BARDA focuses on the end goal: ensuring products are available for the American people and the global community to protect health and save lives from a national security threat or other public health emergency. FDA approval, licensure, and clearance for medical countermeasures is a critical milestone for our partners and for BARDA and demonstrates the success of public-private partnerships in mitigating threats and creating a return on the public investment. That’s why we celebrate every FDA approval, licensure or clearance of a medical countermeasure.

At BARDA, we are excited about the news of the recent FDA approval of an Ebola treatment, EbangaTM (ansuvimab-zykl, formerly known as mAb114), from our partner Ridgeback Biotherapeutics, LP. The treatment is a monoclonal antibody. Monoclonal antibodies bind to a virus protein, reducing the ability of the virus to infect human cells. BARDA and Ridgeback Biotherapeutics partnered in September 2019 for activities required to apply for FDA approval, including late-stage manufacturing of the therapeutic. The success of the program demonstrates the integrated government interagency effort to drive medical countermeasures from bench to bedside.

      -  Early Investment: Scientists from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, discovered, isolated the antibody from a survivor of the 1995 Ebola outbreak in the Democratic Republic of the Congo (DRC) in collaboration with the Institut National de Recherche Biomedicale, the Institute for Research in Biomedicine, and the U.S. Army Research Institute of Infectious Diseases and advanced the product through early clinical development.

 

      - Interagency Clinical Development:   The investigational treatment initially was manufactured by the VRC with support from the Defense Advanced Research Projects Agency (DARPA).], and additional clinical grade production was conducted at NIAID facilities. The product was developed into a powder formulation that did not require freezer storage, which is helpful in natural outbreak settings where freezer storage is sometimes unreliable. The product can be reconstituted onsite at Ebola treatment centers. The product was made available to Ebola patients in the DRC under an expanded access protocol led by the World Health Organization in a trial co-sponsored by NIAID and the National Biomedical Research Institute in the DRC.  In addition, this product was evaluated in the NIAID-sponsored Pamoja Tulinde Maisha (PALM) study.  The PALM study compared the efficacy of three investigational products, including Ebanga , against a control arm of patients receiving an antibody cocktail. Patients treated with Ebanga had improved outcomes over those in the control arm.  The product received FDA Breakthrough Therapy Designation, which helped facilitate development toward approval by the FDA.

 

    -  Development and Clinical Testing: NIAID VRC conducted the Phase 1 clinical trial in healthy volunteers at the NIH Clinical Center. Ridgeback Biotherapeutics, a majority woman-owned business founded in 2014, licensed Ebanga from NIAID and was responsible for leading the development, clinical testing and ultimate FDA licensure of the treatment. Ridgeback and BARDA partnered in September 2019 for late-stage manufacturing and regulatory activities to support licensure.

 

From the isolation of the antibody by government scientists to the ultimate 2020 FDA  approval of the second Ebola therapeutic by a private sector partner, we are honored to be a part of this endeavor which helps make the world a healthier, safer place. For us, number 57 illustrates what government and industry can accomplish together. With novel medicines, diagnostics and vaccines we can save lives, protect the American people and enhance global health security.

Visit our new FDA Approval Page to learn more about our support aiding our partners in achieving the other 56 approvals. While obtaining FDA approval is a major milestone and symbol of development success, regulatory approval is not the end game for those of us in public health preparedness and response. Making sure those products are available when they’re needed is the real end game. Each approval offers an opportunity to recognize the collective and collaborative work of the scientific community, government partners and our industry partners to enhance national health security. Approval number 57 highlights just that, 25 years of public and private partnerships to counter Ebola.

 

...AND WE HAVE MORE IN THE PIPELINE

Explore BARDA's rapidly expanding COVID-19 medical countermeasure portfolio to learn about other exciting products in the pipeline.

Last Updated: December 21, 2020

COVID-19 Medical Countermeasure Portfolio

This award is one component of BARDA's expanding COVID-19 medical countermeasure portfolio; visit BARDA's COVID-19 Portfolio to learn more.

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