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FDA allows first emergency use of a COVID-19 antibody drug

Several states posted daily new records on Tuesday, including more than 12,600 new cases in Illinois, 10,800 in Texas and 7000 in Wisconsin.

Deaths — a lagging indicator, since it takes time for people to get sick and die — are climbing again, reaching an average of more than 930 a day.

Medical staff check on a patient at the COVID-19 intensive care unit of United Memorial Medical Centre in Houston, Texas on Sunday.

Medical staff check on a patient at the COVID-19 intensive care unit of United Memorial Medical Centre in Houston, Texas on Sunday.Credit:Bloomberg

While deaths are still well below the US peak of about 2200 per day back in April, some researchers estimate the nation’s overall toll will hit about 400,000 by February 1.

Early results suggest 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.

Regeneron Pharmaceuticals also has asked for emergency authorisation for REGN-COV2, an antibody drug it is testing, the one Trump received.

FDA regulators authorised the Lilly drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.

In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks.

The emergency authorisation functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Lilly will have to submit additional research to fully define the drug’s safety and benefit for patients.

The government has signed an agreement with Lilly to spend $US375 million ($513 million) to buy 300,000 vials of the drug. How many doses that would provide is unclear. Each vial contains 700 milligrams and that dose proved ineffective in the early results. It took four times that amount — 2,800 milligrams — to show any effect.

The Lilly drug is authorised for people 12 and older who weigh at least 40 kilograms, and who are at high risk for progressing to severe COVID-19 and/or hospitalisation. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

AP

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