October 14, 2020
HHS Secretary Azar Statement on First FDA Approval of Ebola Therapeutic
On Wednesday, the Food and Drug Administration approved Inmazeb, a mixture of three monoclonal antibodies made by Regeneron. This is the first FDA-approved treatment for Ebola virus infection in adult and pediatric patients, following a U.S. government-supported trial and expanded access protocol in the Democratic Republic of the Congo (DRC). HHS Secretary Alex Azar issued the following statement:
“The approval of the first-ever therapeutic for Ebola is a momentous global health achievement that would have never occurred without American leadership. The United States was proud to provide direct support for this treatment, through an expanded access protocol and a clinical trial conducted in a highly dangerous and insecure region of the DRC. The Trump Administration made ending the 2018 Ebola outbreak one of its top global health priorities for the last two years, and these efforts have now left the U.S. and our African partners better prepared for the fight against the new outbreak in western DRC and for future health threats.”
Background on U.S. Efforts to End the Ebola Outbreak
- To support the development of Inmazeb, the United States:
- Led, through the National Institutes of Health and in partnership with the DRC and other international partners, a randomized, controlled clinical trial (RCT) known as the PALM trial assessing four investigational Ebola therapeutics, including Inmazeb.
- Worked closely via the FDA to support development of countermeasures including Inmazeb, including granting the drug Orphan Drug and Breakthrough designations.
- Supported the therapeutic’s development through a public-private partnership between Regeneron and the Biomedical Advanced Research and Development Authority (BARDA), leading to a procurement agreement by BARDA.
- The United States Government (USG) provided in-kind assistance and financial support through established response partners to defeat DRC’s North Kivu outbreak totaling nearly $600 million.
- Through the United States Agency for International Development, the USG has provided more than $365 million to support Ebola preparedness and response efforts in the DRC since Fiscal Year 2018.
- The U.S. Department of State provided robust support in Washington and on the ground in the DRC to facilitate response efforts. For example, U.S. Embassy Kinshasa served as the platform from which U.S. government Departments and Agencies were able to operate in-country. The U.S. Department of State also has supported upgrades to the DRC’s Institut National de la Recherche Biomédicale (INRB) facilities towards the development of a secure biorepository, and, in collaboration with the U.S. National Institutes of Health, will ensure training and equipping efforts to complete inventory of Ebola samples that will be stored in the biorepository.
- HHS mobilized a Department-wide initiative to support the Ebola response efforts in the DRC. HHS, through the Assistant Secretary for Preparedness and Response (ASPR), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), helped develop and deploy medical countermeasures to prevent, treat, and test for the Ebola virus, alongside efforts in the DRC and neighboring countries by the Centers for Disease Control and Prevention (CDC). The Office of Global Affairs (OGA) supported the Secretary in advancing U.S. government and HHS priorities through bilateral and multilateral diplomacy.
- ASPR obligated approximately $278 million through the end of FY 2019 in support of the Ebola outbreak. BARDA has supported the development of three therapeutics, two vaccines, and one rapid diagnostic test related to Ebola. The totality of previous investments under advanced research and development and Project BioShield have supported the ability to make these products available for the outbreak in the DRC, under compassionate use, in clinical trials, or in the National Institute of Allergy and Infectious Disease (NIAID)-sponsored randomized clinical trial. BARDA also made medical countermeasures available in the DRC to support identification of the virus in deceased individuals in order to support safe and dignified burials.
- FDA obligated approximately $8 million in support of the Ebola outbreak response efforts through the end of FY 2019. With this funding, FDA’s primary roles in responding to the Ebola outbreak in DRC include: (1) working closely with medical product sponsors, U.S. government agencies, and regulatory counterparts abroad to help move candidate medical products forward in development as quickly as possible; (2) facilitating access to available medical countermeasures through appropriate regulatory mechanisms; and (3) protecting consumers from unsafe, ineffective, or poor quality medical products.
- In December 2019, the FDA announced the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 18 years of age and older. Because of the public health importance of a vaccine to prevent EVD, the FDA worked closely with the company and completed its evaluation of the safety and effectiveness of this BARDA-supported vaccine, Ervebo, in less than six months.
- NIH obligated about $21 million in support of the Ebola outbreak response in FY 2018 and FY 2019. NIAID, a component of NIH, worked with DRC, WHO, and medical humanitarian organizations to conduct a randomized, controlled clinical trial (RCT) assessing four investigational Ebola therapeutics. The trial enrolled 681 people from November 2018 through August 2019. As reported in the New England Journal of Medicine, the trial found that the investigational treatments mAb114 and REGN-EB3 offer patients an increased chance of survival from Ebola compared to ZMapp.
- CDC obligated approximately $36.7 million in support of the Ebola outbreak response in FY 2018 and FY 2019. Since the Ebola outbreak was first announced in August 2018, CDC has directly supported the response by providing public health response expertise, including in disease surveillance, contact tracing, infection prevention and control, vaccination, case investigation and management, safe and dignified burials, laboratory testing, community engagement and social mobilization, risk communication and health education, behavioral science, laboratory testing, border health, data management, and logistics. CDC deployed 404 staff in 676 deployments for preparedness and response efforts. CDC’s efforts in the DRC continue through deployments to combat the ongoing, smaller outbreak of Ebola in the northwestern DRC.
- OGA support to the Ebola response includes serving as the Department’s focal point for policy, communication, and coordination with the World Health Organization, the Government of the DRC, and neighboring countries’ Ministries of Health.
Read an op-ed by Secretary Azar, CDC Director Robert Redfield, and NIAID Director Anthony Fauci regarding their travel to the DRC and neighboring countries in September 2019: https://www.hhs.gov/about/leadership/secretary/op-eds/on-front-lines-trump-administrations-ebola-response.html