Finally, an FDA-approved Ebola treatment
Over 2 years since the Kivu Ebola epidemic began in August 2018, the US Food and Drug Administration (FDA) approved the first antibody cocktail for the treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. The drug, called Inmazeb, was developed by Regeneron — a biotech company also testing an antibody treatment for COVID-19. In clinical trials, patients who took Inmazeb were far less likely to die from Ebola virus disease.
In the clinical trial conducted during the outbreak in the North Kivu region, those treated with Inzameb experienced 33.5% mortality after 28 days. The World Health Organization (WHO) reports the virus’ mortality rate can be as high as 90%, depending on the outbreak.
The PALM trial, Pamoja Tulinde Maisha (meaning “together save lives”), is a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114, and REGN-EB3, now called Inmazeb) for the treatment of patients with Ebola virus disease. To help control the Ebola virus outbreak, Inmazeb is being administered for free in the DRC with the support of the Biomedical Advanced Research and Development Authority (BARDA), and Regeneron has stated that it is working with non-governmental organizations and public health agencies to make sure the treatment is accessible to low- and middle-income countries.
This trial and other studies done during Ebola outbreaks over the past decade showed that it was possible and operationally feasible to conduct scientific research during an epidemic. Researchers are now applying those lessons during the COVID-19 pandemic. One of the US-based trials for the antiviral remdesivir, which the FDA authorized for emergency use, was modeled after the PALM trial.
“Today’s approval highlights the importance of international collaboration in the fight against Ebola virus,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, in a press release.
Zaire ebolavirus, commonly known as Ebola virus, is one of four Ebolavirus species that can cause a potentially fatal human disease. Ebola virus is transmitted through direct contact with blood, body fluids and tissues of infected people or wild animals, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids. Individuals who provide care for people with Ebola virus, including health care workers who do not use correct infection control precautions, are at the highest risk for infection. Ervebo, the first vaccine for the prevention of Ebola was approved by the European Medicines Agency in October 2019 and the US FDA in December 2019.