With the world focused on the fight against COVID-19, the scientific community just scored a big win against the Ebola virus. The FDA has approved the first treatment—Inmazeb from Regeneron—to treat Zaire ebolavirus in adults and children.
A combination of three monoclonal antibodies, the medicine was born from the same technology Regeneron is using in its COVID-19 antibody work. Regeneron has been developing Inmazeb since 2015 under a partnership with the U.S. government's Biomedical Advanced Research and Development Authority (BARDA), which helped fund R&D.
“As we apply the same sophisticated technologies and manufacturing capabilities against COVID-19, we hope this will be one of many demonstrations of how the power of science can be successfully deployed against dangerous infectious diseases,” Regeneron Chief Scientific Officer George Yancopoulos, M.D., Ph.D., said in a statement.
Under a deal struck in July, Regeneron will deliver doses of the drug to the U.S. government over the next six years for outbreak preparedness. In return, the government will pay the company $10 million next year and an average of $67 million annually between 2022 and 2026.
Further, with BARDA backing, Regeneron will provide the Ebola drug to fight an outbreak in the Democratic Republic of Congo. The company is working with nonprofits and health authorities to enable access in low- and middle- income countries.
Separately, Regeneron also has a $450 million deal with BARDA to supply its COVID-19 antibody if it wins an FDA approval or emergency use authorization. During the COVID-19 pandemic, BARDA has teamed up with 66 companies, including leading vaccine, diagnostic and therapeutic players, according to its website.
“BARDA is continuing our collaboration with Regeneron on other life-threatening diseases such as MERS and COVID-19, and we look forward to continued success,” BARDA acting Director Gary Disbrow, Ph.D., said in a statement.
Ebola is a deadly disease transmitted through direct contact with bodily fluids or tissue of infected people, or through surfaces such as bedsheets. Healthcare workers who care for Ebola patients and who don’t use proper methods to control infections are at a high risk, according to the FDA.
Regeneron’s drug binds to the glycoprotein on the surface of the Ebola virus and prevents it from entering cells. The med scored approval based on a trial conducted from 2018 to 2019 in the Democratic Republic of Congo. The study showed Regeneron's drug was better at cutting death risks than other investigational drugs ZMapp from Mapp Biopharmaceutical and remdesivir from Gilead Sciences, which has an emergency authorization to treat COVID-19.
The Ebola trial evaluated the medicines in 681 patients, and, in 2019, investigators stopped the trial early after a pre-specified interim analysis showed Regeneron’s drug was better than the other meds at helping patients survive. Some patients on the Regeneron medicine experienced fever, chills, vomiting and faster heart rate and breathing, but the FDA noted those are also symptoms of Ebola infections.
Thursday's FDA nod marks another milestone in the fight against Ebola after deadly outbreaks in recent years. Two vaccines from Merck and Johnson & Johnson have also scored their own regulatory green lights.
Meanwhile, the approval also underscores the importance of collaborations between industry, governments and others to respond to new and infectious diseases. Experts have long said the world is unprepared for future pandemics, and the COVID-19 outbreak made that plainly clear.
But the unprecedented collaborations seen during the coronavirus pandemic show how the scientific community can respond, and looking forward, pandemic preparedness is likely to be an important subject for health officials.