Eli Lilly and Company’s bamlanivimab wins EUA for COVID-19 treatment

• Eli Lilly and Company has reportedly received an EUA (emergency use authorization) by the U.S. FDA for its monoclonal antibody vaccine, bamlanivimab.
• Bamlanivimab will be used for the treatment of mild-to-moderate COVID-19 cases in pediatric patients and individuals above the age of 65 who suffer from pre-existing chronic ailments.

According to reliable sources, Indianapolis-headquartered pharmaceutical organization, Eli Lilly and Company has received an EUA (emergency use authorization) by the U.S. FDA (Food and Drug Administration) for its monoclonal antibody vaccine, bamlanivimab.

For the record, bamlanivimab will be used for the treatment of mild-to-moderate COVID-19 cases in pediatric patients with a minimum weight of 88 pounds as well as adults, primarily individuals above the age of 65 who suffer from pre-existing chronic ailments.

As per credible reports, the phase 2 clinical trials of the treatment involved 452 participants. It was observed that around 1.6% of the 309 participants injected with bamlanivimab and 6.3% of the 143 patients subjected to placebo were hospitalized with the Coronavirus.

Apparently, the authorization will aid healthcare professionals to offer an alternative treatment option for remdesivir, an experimental drug by U.S.-based biopharmaceutical company, Gilead Sciences, Inc., which recently received an FDA approval.

On the contrary, the FDA claims that monoclonal antibodies such as bamlanivimab may be associated with worse clinical outcomes when subjected to patients that require mechanical ventilation for high flow oxygen due to the COVID-19 virus, as cited by credible sources.

Acting Director of the FDA’s Center for Drug Evaluation & Research, Dr. Patrizia Cavazzoni, was reported saying that the regulator will continue to evaluate the efficacy and safety of bamlanivimab while it is publicly circulated by the government.

Sources close to the matter cite that Eli Lilly will begin the shipment of the vaccine to American drug wholesale company, AmerisourceBergen Corporation, which will further distribute it as instructed by the U.S. government.

In other developments, United Kingdom’s publicly funded healthcare system, National Health Service (NHS) is planning a mass distribution of COVID-19 vaccines by the end of November.

 

Source credits: https://www.foxbusiness.com/healthcare/eli-lilly-covid-19-treatment-given-fda-clearance-for-emergency-use