US regulators have approved Regeneron’s Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and paediatric patients, including newborns of mothers who have tested positive for the infection.
“This is the first time the FDA has approved a treatment specifically for Ebola, which has caused a number of deadly outbreaks,” said George D. Yancopoulos, President and Chief Scientific Officer of Regeneron.
“Decades of investment in our VelociSuite rapid response technologies, the dedication of world-class scientists, and the courageous contributions of healthcare providers and patients, together with remarkable cooperation between leading international health organizations and governments, have led to this important moment.
“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.”
As part of an agreement announced in July 2020, Regeneron will deliver an established number of Inmazeb treatment doses over the course of six years to the Biomedical Advanced Research and Development Authority (BARDA), as part of the US Department of Health and Human Services’ (HHS) goal of building national preparedness for public health emergencies.
The safety and efficacy of Inmazeb was established through the 681-patient PALM Trial, a randomized, multicenter, controlled trial initiated in 2018 in the DRC.