FDA issues emergency use authorization for bamlanivimab as COVID-19 Rx
(RxWiki News) The US Food and Drug Administration (FDA) has approved a new COVID-19 treatment.
This medication is found under the name bamlanivimab. The FDA approved it to treat mild to moderate COVID-19.
More specifically, bamlanivimab is approved for those who are at high risk of severe COVID-19 and/or hospitalization.
This investigational drug was granted an emergency use authorization (EUA). It belongs to a class of drugs called monoclonal antibodies, and it’s approved to treat adults and children who are at least 12 years old and weigh at least 40 kilograms (around 88 pounds).
When a drug is called “investigational,” that means it is still being studied. There is still limited information about this drug and its safety or effectiveness.
These drugs work by mimicking the immune system in how it fights viruses. Specifically, this medication attempts to block the virus from attaching to and entering the body’s cells.
“The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” said Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, in a press release. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”
This medication is not approved for those who are already in the hospital with COVID-19 and who are in need of oxygen therapy or mechanical ventilation, the FDA noted.
The EUA for bamlanivimab was based on data from a clinical trial that looked at nearly 500 people with mild to moderate COVID-19 symptoms in a non-hospital setting.
This medication is available as an injection to be administered into the vein by a health care provider as a one-time dose.
Potential side effects include nausea and vomiting, diarrhea, dizziness, headache and itching. In addition, reactions related to administration of the drug may occur. These can include pain, bleeding, bruising, soreness or swelling where the medication is given.
Another possible side effect is a serious and life-threatening type of allergic reaction called anaphylaxis. Tell your health care provider right away if you notice swelling of your lips, face or throat.
The FDA issued this EUA to Eli Lilly and Company.