FDA Approves Regeneron’s Inmazeb as the First Treatment for Ebola

October 15, 2020
Pharmaceutical Technology Editors

Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.

Regeneron Pharmaceuticals announced on Oct. 14, 2020 that FDA has approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus (Ebola) in adult and pediatric patients.

Under the terms of the approval, Regeneron will distribute Inmazeb treatment doses over the course of six years to the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, a company press release said.

“We are incredibly proud that [FDA] has approved Inmazeb, which is also known as REGN-EB3. This is the first time [FDA] has approved a treatment specifically for Ebola, which has caused a number of deadly outbreaks,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, in the press release. “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.”

“Since 2015, BARDA has partnered with Regeneron to develop a life-saving treatment for Ebola Zaire. The [FDA]’s approval of Inmazeb shows the power of public private partnerships to bring forward these critical treatments and improve global public health,” said Gary Disbrow, the acting director of BARDA, in the press release. “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.”

Source: Regeneron