WASHINGTON (Pakistan Point News / Sputnik - 15th October, 2020) ASHINGTON, October 15 (Sputnik) Inmazeb, a mixture of three monoclonal antibodies, became the first medication approved to treat the deadly Ebola virus, the US food and Drug Administration (FDA) said in a press release.
"Inmazeb was evaluated in 382 adult and pediatric patients with confirmed Zaire ebolavirus infection in one clinical trial (the PALM trial) and as part of an expanded access program conducted in the Democratic Republic of the Congo (DRC) during an Ebola virus outbreak in 2018-2019," the release said on Wednesday.
In the PALM trial, Inmazeb was evaluated in a randomized controlled trial, in which 154 patients received Inmazeb (50 mg of each monoclonal antibody) intravenously as a single infusion, and 168 patients received an investigational control, the release added.
Of the 154 patients who received Inmazeb, 33.8 percent died after 28 days, compared to 51 percent of the 153 patients who received a control.
The World Health Organization (WHO) declared the DRC Ebola outbreak over on June 25, 2020. Of 3,480 cases, 2299 people died and 1,162 survived.
The FDA warned that some patients experienced side effects of Inmazeb and said the drug should be discontinued "in the event of a hypersensitivity reaction."
In addition, the release said the drug should not be taken by patients who received the FDA approved vaccine Ervebo, which was widely administered during the DRC outbreak.
The vaccine uses a live but weakened virus and Inmazeb could limit replication of the virus, the FDA said.
Monoclonal antibodies are grown in a laboratory to mimic antibodies produced by the body to fight an infection.
