AbCellera antibody gets US FDA EUA as monotherapy for COVID-19 treatment

Bamlanivimab over a microscope image of COVID-19 viruses above FDA EUA

The drug, called bamlanivimab, is meant to be used in patients 12-years-old and up with mild or moderate COVID-19 who do not yet require hospitalization, the FDA said in a release on Monday, adding that the treatment is specifically meant to treat people at high risk for developing more severe symptoms - including those 65 and older who have chronic medical conditions.

"While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo", the FDA said.

However, the US FDA noted that bamlanivimab is not authorised for patients who are hospitalised due to Covid-19 or require oxygen therapy due to Covid-19.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses, according to the FDA.

The US government will allocate 300,000 doses of bamlanivimab to high-risk patients, with no out-of-pocket costs for the medication.

Bamlanivimab is a recombinant monoclonal antibody targeting the SARS-CoV-2 spike protein. Eli Lilly suggests the treatment should be administered as soon as possible after a positive COVID-19 test, and no later than 10 days after symptoms have appeared. We still have a long way to go before one is available, so do not forget to continue wearing your mask, washing your hands, and keeping your distance from others.

The study, which ran from July 17 to August 21, recruited a total of 467 patients, 452 of whom had their data used for the interim analysis.

The White House, in an emailed statement, hailed the FDA's decision as "a major milestone".

Regeneron is now seeking emergency approval for a dual-antibody against COVID-19. Details regarding the EUA and Lilly's plans to make COVID-19 therapies broadly available to patients, including its agreement to provide the USA government with 300,000 doses, can be found here.

Lilly said in a statement that it will begin shipping the antibody immediately to AmerisourceBergen, which is set to distribute the treatment as instructed by the United States government's allocation programme. Another one million doses should be available to the rest of the world by the end of 2020 with manufacturing expanding in early 2021.



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