The FDA has granted emergency approval to a new COVID drug treatment. The drug is manufactured by Eli Lilly, a pharmaceutical company in the United States. It is called Bamlanivimab and is a monoclonal antibody that keeps the disease from progressing.
Monoclonal antibodies are molecules made in the laboratory. They act as substitute antibodies that can either mimic, enhance, or restore the immune system’s attack on cells.
In clinical trials, Bamlanivimab resulted in a decreased viral load and reduced emergency room visits and hospitalizations for COVID-19.
The treatment is administered intravenously in one dose.
What Is Emergency Use Authorization?
It is a provision of the Federal Food, Drug, and Cosmetic Act that allows for the use of a medication that has not FDA approved under certain conditions.
“The FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives,” states the FDA site.
CBRN stands for chemical, biological, radiological, nuclear.
Bamlanivimab continues to be evaluated through testing to establish effectiveness and safety.
Who Is The Treatment Intended For?
The company that manufactures the drug states that it should be administered as soon as possible after an individual tests positive for the virus and within ten days of the first symptoms. The authorization is for adults and children at least 12 years old and weighing at least 88 pounds.
Other indications include:
- A mild to moderate case of the illness
- Are at risk for developing a severe case of COVID-19 or being hospitalized, including individuals 65 years or older or certain chronic medical conditions.
The authorization does not include patients already hospitalized, those who require oxygen therapy due to COVID-19, or anyone who needs oxygen for another condition and requires an increase in their oxygen flow rate due to COVID-19.
The US government has purchased 300,000 doses of Bamlanivimab. Americans will not be charged with any out-of-pocket costs for the drug itself. That does not mean that it will be completely free. Healthcare facilities may charge to administer the treatment.
Potential Side Effects of Bamlanivimab
As with any medication, there is the possibility of an allergic reaction. In the clinical trial that was conducted on 850 participants, there was one severe allergic reaction.
Parentology reported on FDA approval of Remdesivir for the treatment of patients who have been hospitalized for the virus.
As COVID-19 cases are surging globally, it is welcome news that healthcare providers have another treatment available to help fight the disease.
New COVID Drug — Sources
FDA – Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab
FDA – Coronavirus (COVID-19) Update: November 9, 2020
FDA – Emergency Use Authorization
Eli Lilly – Lilly’s neutralizing antibody Bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19