Antibody cocktail REGN EB3 (Inmazeb) is the first FDA approved treatment for Ebola.-Regeneron

Regeneron Pharmaceuticals, Inc. announced that the FDA approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric 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. 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 U.S. Department of Health and Human Services’ (HHS) goal of building national preparedness for public health emergencies. In keeping with our mission and values, Regeneron is committed to making this important medicine available to the people who need it. In response to the 2018 Ebola outbreak in the Democratic Republic of the Congo (DRC), the company worked with the World Health Organization (WHO), U.S. FDA and other global organizations to offer Inmazeb under a compassionate use protocol and include it in the four-arm PALM (PAmoja TuLinde Maisha) Trial. With BARDA support, the company continues to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use. Regeneron is actively working with non-governmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries. 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. The WHO, the National Institutes of Health (NIH) and the Institut National de Recherche Biomédicale (INRB) in the DRC jointly sponsored and served as co-principal investigators of the trial. In 2019, as reported in the New England Journal of Medicine, the PALM Trial was stopped early following a pre-specified interim analysis that showed superiority of Inmazeb to ZMapp and remdesivir with respect to mortality. Adverse events that occurred in at least 10% of Inmazeb patients were chills, elevation in fever (pyrexia), rapid heartbeat (tachycardia), rapid breathing (tachypnea), vomiting, low blood pressure (hypotension), diarrhea and inadequate oxygen supply to the tissue (hypoxia); of these, only chills occurred more frequently with Inmazeb than ZMapp. The evaluation of AEs in Inmazeb patients may have been confounded by the signs and symptoms of the underlying Zaire ebolavirus infection. See- "A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics" Sabue Mulangu et al. NEJM November 27, 2019 DOI: 10.1056/NEJMoa1910993