US allows 1st emergency use of a COVID-19 antibody drug
Published:Tuesday | November 10, 2020 | 9:55 AM
WASHINGTON (AP) — United States health officials have allowed emergency use of the first antibody drug to help the immune system fight COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans.
The Food and Drug Administration on Monday cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalisation.
It’s a one-time treatment given through an IV.
The therapy is still undergoing additional testing to establish its safety and effectiveness.
It is similar to a treatment President Donald Trump received after contracting the virus last month.
Early results suggest the drug, called bamlanivimab, may help clear the coronavirus sooner and possibly cut hospitalisations in people with mild to moderate COVID-19.
A study of it in hospitalised patients was stopped when independent monitors saw the drug did not seem to be helping in that situation.
The government previously reached an agreement to buy and supply much of the early production of Lilly’s drug.
Only one drug -- Gilead Sciences’ remdesivir -- has full FDA approval for treating COVID-19.
Government treatment guidelines also back using dexamethasone and other steroids for certain severely ill, hospitalised patients.
One other treatment has an emergency use designation now — convalescent plasma, or the blood of COVID-19 survivors.
No large studies have shown it to be more effective than usual care alone, however.
The new drug is part of an emerging family of biologic therapies that offer a promising new approach to preventing serious disease and death from COVID-19.
Experts say the infused drugs could serve as a therapeutic bridge to help manage the virus until vaccines are widely available.
The drugs are laboratory-made versions of antibodies, blood proteins which the body creates to help target and eliminate foreign infections.
The new therapies are concentrated versions of the antibodies that proved most effective against the virus in patient studies.
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