U.S. FOOD AND DRUG ADMINISTRATION (FDA) APPROVES NEW EBOLA VIRUS DRUG EBANGAby 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 (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 enterpriseFounded 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.