U.S. FOOD AND DRUG ADMINISTRATION (FDA) APPROVES NEW EBOLA VIRUS DRUG EBANGA : Healthcare, Digital Marketing and Market Access Strategy - John G. Baresky
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by John G. Baresky on 12/30/20

FDA Approves Ebanga (ansuvimab-zykl): A New Ebola Virus Treatment

Ridgeback Biotherapeutics has earned FDA approval for its new Ebola virus treatment therapy Ebanga (Ansuvimab-zykl). Ebanga is a monoclonal antibody (mAb) that is issued an indication for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children.

Available by prescription only, Ebanga is an injectable product. Its method of action prevents the binding of the Ebola virus to the cell receptor so that it cannot make entry into and infect the cell.

Ebola is a highly contagious and potent viral pathogen


Ebola virus disease (EVD) outbreaks signal instant medical emergencies that demand the swift attention of healthcare professionals and government health officials. The virus is most prevalent in sub-Saharan Africa. Its victims can contract EVD by direct contact with or the bodily fluids of an infected creature (bats, nonhuman primates, assorted mammals) or a human –including the bodies of EVD fatalities.

There are 6 varieties of Ebola virus; these 4 are harmful to humans:


  • Bundibugyo ebolavirus (BDBV)
  • Sudan ebolavirus (SUDV)
  • Tai Forest (TAFV - formerly referred to as Ebola Ivory Coast)
  • Zaïre ebolavirus (EBOV)


If outbreaks occur in remote areas there are less sources of medical care for Ebola victims to go to for treatment so deaths or severe suffering by patients occur as it is difficult for medical professionals to reach them quickly. This issue becomes magnified due to Ebola's ability to emerge and spread suddenly while deploying its harmful ability to generate deadly symptoms in its victims.

The FDA prioritized Ebanga’s evaluation and approval process

As Ebola is a significant and deadly threat the FDA and other regulatory authorities are eager to help facilitate the review of products which may be effective in treating it.

The FDA took action to accelerate the process to assess Ebanga so it could be evaluated sooner and once approved be made available to medical professionals and their patients more quickly. 

The agency deployed these and other measures to support an expedited review of it:

Ridgeback Biotherapeutics is a compact biopharma enterprise

Founded in 2016, Ridgeback Biotherapeutics is headquartered in Miami, Florida. In addition to its success with Ebanga, it has a strategic partnership with Merck (NYSE: MRK) focused on the development of a COVID-19 antiviral agent. Ridgeback Biotherapeutics is privately held. 

Ebanga joins Ervebo and Inmazeb as mainstay therapeutic options to treat or prevent Ebola 

In October 2020 Regeneron's (NASDAQ: REGEN) novel biotherapy Inmazeb achieved FDA approval to treat Ebola virus. Inmazeb is a complex antiviral therapy that consists of a combination of 3 monoclonal antibodies:
  • Atoltivimab
  • Maftivimab
  • Odesivimab
In December of 2019, Merck's Ervebo (rVSV-ZEBOV-GP) vaccine was approved by the FDA and Europe's CHMP to immunize against Ebola virus.

Congratulations are in order for Ridgeback Biotherapeutics success during 2020 in developing an effective agent to combat Ebola virus while pursuing the creation of a COVID-19 antiviral therapy with Merck.

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