- The Food and Drug Administration on Monday approved an Ebola virus treatment from Ridgeback Biotherapeutics, clearing the second drug to emerge from a groundbreaking 2018-2019 study of the terror-inducing disease.
- Researchers working in the Democratic Republic of Congo found the medicine, now known as Ebanga, could help prevent people infected with Ebola from dying, compared with a control drug called ZMapp. The lower mortality rate with Ebanga was roughly similar to that of Regeneron’s Inmazeb, which in October became the first medication approved by the FDA for the virus.
- Both Ebanga and Inmazeb are antibody treatments given as infusions. Ebanga is a single human monoclonal antibody, while the Regeneron treatment employs three synthetic antibodies against the Ebola virus.
Ebanga offers another defense against an extremely lethal disease. The largest Ebola outbreak, which occurred from 2014 to 2016 in West Africa, killed more than 11,000 people.
In the DRC study, known as PALM, about half of the patients given ZMapp died within 28 days, compared with 35% of study participants given Ebanga. The trial included both adults and children.
Patients on Ebanga suffered a variety of symptoms such as fever, vomiting and tachycardia, but those are also symptoms of Ebola virus infection, the FDA said. The agency warned that doctors should be alert to hypersensitivity and avoid giving the medicine at the same time as an Ebola vaccine, two of which are now available.
While the FDA's approval was granted to Ridgeback, Ebanga was developed by scientists from the U.S. National Institute of Health's Vaccine Research Center and the DRC's National Institute of Biomedical Research. Ridgeback later licensed the drug, and received U.S. government funding for its development.
Antibody therapies work by binding to a virus and blocking it from invading healthy cells. Regeneron in November won an emergency authorization of its COVID-19 antibody therapy, which was used to treat President Donald Trump. Eli Lilly & Co. has won a similar clearance for its COVID-19 antibody treatment.
Ridgeback, meanwhile, has entered a partnership with Merck for a potential oral treatment for COVID-19. The privately held company originally licensed the medicine, EIDD-2801, from Emory University and in May announced plans to sell exclusive worldwide rights to Merck.
Merck says the capsule, now known as molnupiravir, is being studied in more than 2,700 patients in Phase 2/3 trials and has the potential to treat a number of other viral infections, including from the SARS and MERS viruses. In October, the company told investors it expected to be able to produce millions of doses by the end of this year.