First Ebola therapy approved by the FDA

For the first time, an Ebola therapy has been approved for use. The Food and Drug Administration on Wednesday approved Inmazeb, an antibody cocktail made by Regeneron Pharmaceuticals.

With the approval, there are now both a vaccine — Merck’s Ervebo — and a therapeutic to battle Ebola Zaire, tools that for decades were out of reach for Ebola, which is one of the deadliest infections known to humankind. There is currently an outbreak in the Democratic Republic of the Congo, the third in the last three years in that country.

“This is the first time the FDA has approved a treatment specifically for Ebola, which has caused a number of deadly outbreaks,” said George Yancopoulos, Regeneron’s president and chief scientific officer, in a statement. “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.”

Inmazeb, which is made up of three monoclonal antibodies, was shown to be effective in treating the Zaire strain of Ebola in a clinical trial conducted during the 2018-2020 North Kivu outbreak in eastern DRC. The trial was stopped early, in August 2019, after Inmazeb — then known at REGN-EB3 — was seen to be statistically better than the other therapies it was being tested against.

In the trial, 33.8% of patients who received the treatment died from their infections, compared to 51% of patients who received a control — a different monoclonal cocktail known as ZMapp. Mapp Biopharmaceutical, which was developing ZMapp, has since abandoned the product.

The Tarrytown, N.Y.-based Regeneron is also developing a monoclonal antibody therapy for Covid-19. Although it is still in clinical trials, it was given to President Trump earlier in the month when he was hospitalized at Walter Reed National Military Medical Center after contracting Covid-19. He has since touted the cocktail as a cure for the infection.

The Biomedical Advanced Research and Development Authority has purchased an undisclosed number of doses of Inmazeb for the U.S. strategic national stockpile. The agreement, announced last July, requires the company to deliver the doses over a course of six years. Regeneron will earn approximately $10 million in 2021 and an average of $67 million per year for each of the next five years from the deal.

The company said it will also work to ensure low-income countries that need the treatment have access to it. The treatment has been used in the current DRC outbreak under a compassionate use protocol.

In bringing to market a therapeutic to treat Ebola, Regeneron will be awarded a priority review voucher, which the company can redeem to receive fast-tracked review of a future drug application before the FDA. Priority review vouchers can also be sold, and can earn tens of millions of dollars for the seller.

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