Regeneron Pharmaceuticals, Inc. has announced that it has been granted approval from the U.S. Food and Drug Administration (FDA) to distribute Inmazeb, a multiple antibody cocktail aimed at treating the Zaire ebolavirus.
Ebola is known to cause internal bleeding and eventually death and caused an epidemic in Africa from 2013 to 2016 and had spread to other countries such as the United States. The disease resurfaced in 2018 in the Democratic Republic of the Congo, prompting Regeneron to take action to find a better solution, resulting in producing Inmazeb.
Inmazeb, known as REGN-EB3, is a concoction of three antibodies that aims to treat the ebolavirus infection in adult and pediatric patients. Through a series of trials, Regeneron found that Inmazeb proved to be more effective and with a lower mortality rate than the current gold standard treatment, ZMapp.
“We are incredibly proud that the FDA has approved Inmazeb, which is also known as REGN-EB3. This is the first time the FDA has approved a treatment specifically for Ebola, which has caused a number of deadly outbreaks,” says George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
Regeneron is working with the Biomedical Advanced Research and Development Authority (BARDA) to administer Inmazeb doses to patients over the span of six years. This plan is set to satisfy the U.S. Department of Health and Human Services’ (HHS) wishes to build awareness and prepare for widespread disease outbreaks.
“We are moved to know our therapy is helping save the lives of people facing this deadly infectious disease,” says Regeneron’s Executive Vice President of Research and Development, Neil Stahl, Ph.D. “We look forward to working with governments and other collaborators, including BARDA, to make REGN-EB3 available for the current outbreak and future use.”
If the phrase “multiple antibody cocktail” seems familiar, it should: Regeneron’s work in developing Inmazeb utilized the same new development process used in the development of REGN-COV2, the antibody treatment given to U.S. President Donald Trump just a few weeks ago, leading to his apparent speedy recovery from COVID-19 infection.