FDA Approves First-Ever Ebola Antibody Cocktail Treatment
The Food and Drug Administration (FDA) has announced that it has approved Inmazeb by Regeneron Pharmaceuticals, a mixture of three monoclonal antibodies. This constitutes the FDA's first-ever approval of a treatment for patients infected by the Ebola virus.
The drug was shown to reduce the disease's mortality rate from 51 percent to 33 percent in clinical trials conducted in 2018-2019.
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The FDA's approval is also a good sign for similar therapies being developed for COVID-19, that may be approved before any vaccine is developed.
Monoclonal antibody Ebola treatment
Though a 97-percent-effective Ebola vaccine, Ervebo, was approved late last year, Inmazeb may help to treat patients of an ongoing outbreak in the Democratic Republic of Congo, which started in June.
The new FDA-approved Ebola treatment, Inmazeb, is a combination of three monoclonal antibodies made by Regeneron Pharmaceuticals. These antibodies target the protein that coats Ebola virus particles, the glycoprotein. The virus infects humans by uses this glycoprotein to stick to human cells before entering them.
As an FDA press statement explains, "the three antibodies that make up Inmazeb can bind to this glycoprotein simultaneously and block attachment and entry of the virus."
Clinical trials for Inmazeb Ebola treatment
During the clinical trials conducted between 2018-2019, 154 Ebola patients were given Inmazeb. 33.8 percent of these patients died after 28 days, compared with 51 percent of 153 patients who received a control.
The Democratic Republic of Congo (DRC) is currently undergoing its 11th outbreak of Ebola since it was first identified in 1976. Starting on June 1 of this year, 100 people have so far been infected and 47 have died.
The largest recorded Ebola outbreak was the 2014 West African outbreak, which saw more than 28,000 cases and 11,000 deaths.
Regeneron hoping for COVID-19 treatment approval
The FDA approval of Regeneron's Ebola treatment comes as the company recently hit the news for its monoclonal antibody treatment for COVID-19. The treatment, which utilizes two monoclonal antibodies, is still in clinical trials but was recently administered to US President Donald Trump on a "compassionate use" basis.
In a September press release, Regeneron claimed that its REGN-COV2 treatment "reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients."
Though REGN-COV2 has not yet been sufficiently tested to be officially called a COVID-19 treatment — or a "cure" as President Trump has prematurely and unsurprisingly dubbed it — Regeneron has requested that the FDA issue an Emergency Use Authorization so that it can be more widely used amid the ongoing COVID-19 pandemic.