Ebola treatment by Ebanga approved by FDA

-By KI News Team | Jan. 11, 2021, 8:23 p.m.

A new drug Ebanga (Ansuvimab-zykl), by Ridgeback Biotherapeutics, LP finally stands as the second approved drug by FDA, against Ebola Zaire ebolavirus (Ebolavirus) infection in adults and children, which is isolated from the human monoclonal antibody. It blocks the binding of Ebola virus to the cell receptor that  blocks the entry of virus into the cell. The drug had been granted US Orphan Drug designation and Breakthrough Therapy designations.

Zaire ebolavirus (Ebolavirus) is a type of disease that often concludes in fatality. It transmits via body fluids like blood and tissues of diseased people or wild animals. The infection can pass through surfaces and materials, such as bedclothes and clothing, that are polluted with these fluids. The virus’s incubation time is around 6-10 days. If not treated it can result in inflammatory cytokines trigger and cause multi organ failure or shock.

Inmazeb (antibody therapy) by Regeneron Pharmaceuticals was developed in 2019. Exactly after one year the new treatment of Ebanga is approved. The drug was approved after trials conducted by PAmoja TuLinde Maisha (PALM [together save lives]) [PALM Trials] under Democratic Republic of the Congo (DRC) in 2018 - 2019. The trial concluded with affirmative results, out of 174 patients who were Ebola positive (120 adults and 54 pediatric patients) only around 35.1% died after a dose of 50mg/kg of Ebanga. When compared to the control that concluded in death of 49.9% of patients out of 168 patients.

The symptoms after the administration are carefully observed and if any signs of hypersensitivity reaction is observed, the treatment were withdrawn, which maybe the signs of the treatment not being successfully delivered on the individual. The people receiving the vaccination for Ebola are not advised by the Ridgeback Biotherapeutics, LP, to take Ebanga as it will counteract the effect of vaccine.

The most common symptoms experienced while receiving Ebanga include: fever, tachycardia (fast heart rate), diarrhea, vomiting, hypotension (low blood pressure), tachypnea (fast breathing) and chills; but these are also common symptoms of Ebola Virus infection.

Wendy Holman, CEO and Co-founder of Ridgeback Biotherapeutics added in the press releaseThe devoted Ridgeback team embarked on this mission with one goal in mind – to stop the spread of Ebola and stop the devastation created by this aggressive disease. The Ridgeback team has been tireless in their efforts, united in their mission and focused on bettering the lives of the patients we impact. I am so thankful to this committed team and I look forward to how we can further our mission of helping people by serving unmet needs for those with grievous illness.”

The drug has crossed the trial stages and is ready to be delivered to the Ebola patients in Africa throughout the DRC’s 11th Ebola outbreak in Équateur Province. The patients with Ebola PCR-positive were considered for the treatment.

Drug Information:

  • Brand name: Ebanga
  • Generic name: ansuvimab-zykl
  • Active Ingredients: Ansuvimab
  • Inactive Ingredients: Histidine, Histidine monohydrochloride, Polysorbate 80 and Sucrose
  • Dosage form: Injection, Intravenous use
  • Type: Prescription Only
  • Dosage400 mg lyophilized powder in a single-dose vial
  • Storage Temperature: Refrigerated at 2°C to 8°C (36°F to 46°F)
  • Available Content: 1 x 36 x 400 mg vials