U.S. regulators on Monday cleared the emergency use of the first experimental antibody to COVID-19 in patients who are not hospitalized but are at risk of serious illness due to their age or other conditions.
The Food and Drug Administration (FDA) granted Emergency Use Clearance (EUA) for Eli Lilly & Co’s bamlanivimab based on trial data showing that a single infusion of the treatment reduced the need for hospitalization or emergency room visits in high-risk COVID cases. 19 patients.
The drug is a monoclonal antibody – a widely used class of biotech drugs which in this case is a fabricated copy of an antibody that the human body creates to fight infections.
A similar treatment developed by Regeneron Pharmaceuticals Inc was given to US President Donald Trump after catching the coronavirus in early October. The nation’s top infectious disease specialist, Dr Anthony Fauci, said it likely helped Trump’s recovery.
The White House, in an emailed statement, hailed the FDA decision as “a major step.”
Regeneron is also looking for an EUA for its double antibody against COVID-19.
The FDA has said Lilly’s antibody can be used for anyone over 65 who has recently been diagnosed with mild to moderate COVID-19 and for patients aged 12 and over who have a medical condition. underlying that puts them at risk of serious illness.
It was not authorized for hospitalized patients or for those who required oxygen therapy due to COVID-19, as it could worsen the clinical outcomes of these patients. A US government-sponsored study of bamlanivimab in hospitalized patients with COVID-19 was recently abandoned because the treatment was not found to be helpful.
Lilly said she would immediately begin shipping bamlanivimab through distributor AmerisourceBergen, but regional allocations for the drug will be determined by the federal government.
The U.S. government has purchased 300,000 doses of the treatment and has pledged that Americans will not have to pay for the drug, although healthcare facilities may charge a fee for administering the product.
Lilly plans to manufacture up to one million doses of bamlanivimab by the end of 2020, for use worldwide until early next year. Beginning in the first quarter of 2021, he expects the supply to increase significantly, as additional manufacturing resources come online.
As part of the EUA, the FDA said Lilly would retain an independent third party to perform a review of the records and the underlying data and associated deviations of the drug substance bamlanivimab manufactured at the company’s Branchburg plant, in New Jersey.
On October 13, Reuters reported that inspectors who visited the Branchburg plant in November 2019 found that data on various manufacturing processes had been removed and had not been properly audited, according to inspection documents from the government.
Lilly said she plans to apply for a similar clearance in November for her two-antibody cocktail, which she described as having helped lower viral levels even more than single-antibody treatment.
Shares of the Indianapolis drugmaker, which closed little change at $ 142.33 in regular trading, rose 3.6% after hours.
(This story was not edited by GalacticGaming staff and is auto-generated from a syndicated feed.)