FDA approves Regeneron’s antibody Ebola treatment

pharmafile | October 15, 2020 | News story | Research and Development Ebola, ebola antibody., ebola treatment 

The FDA has approved Regeneron’s antibody drug inmazeb for treating Ebola.

The treatment works through targeting the glycoprotein on the surface of the virus. Glycoproteins attach to the cell receptor and fuses with the viral and host cell membranes, allowing the virus to enter cells. The antibodies in the drug bind to these glycoproteins to block the attachment and the entry of the virus. 

FDA Commissioner Stephen M. Hahn said: “Today’s action demonstrates the FDA’s ongoing commitment to responding to public health threats – both domestically and abroad – on the basis of science and data. This approval was made possible because of our steadfast dedication to facilitate the development of safe and effective treatments for infectious diseases as part of our vital public health mission.”

The approval comes following the PALM clinical trial which evaluated 382 adult and paediatric patients who had an Ebola infection as part of an expanded access programme in the Democratic Republic of Congo during an outbreak in 2018-2019. It was led by the US National Institutes of Health and the DRC’s Institut National de Recherche Biomedical in collaboration with several other international organisations. 

154 patients received the treatment intravenously as a single infusion and 168 received an investigation control. Of the patients who received inmazeb, 33.8% died after 28 days, compared to 51% of the 153 patients who received a control. Patients who took the treatment did experience some side-effects including fever, chills, faster breathing, increased heart rate and vomiting, although these could also be symptoms of the virus. These results were published in the New England Journal of Medicine

Dr John Farley, M.D., MPH, Director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, also commented and said: “Today’s approval highlights the importance of international collaboration in the fight against Ebola virus. The urgent need for advanced therapies to combat this infectious disease is clear, and today’s action is a significant step forward in that effort.”

The FDA approved the first vaccine for Ebola in December, after receiving complete data from trials conducted in Guinea during the 2014-2016 outbreak. 

Conor Kavanagh

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