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U.S. health officials cleared emergency use of first monoclonal antibody to help fight immune system COVID-19[female[feminine, an experimental approach against the virus that has killed more than 238,000 Americans.
The Food and Drug Administration on Monday cleared Eli Lilly’s investigational drug for people 12 years of age and older with mild or moderate symptoms of COVID-19 who do not require hospitalization. It is a unique treatment administered intravenously.
The therapy is still undergoing further testing to establish its safety and effectiveness. It’s similar to treatment President Trump received after contracting the virus last month.
Lilly’s studies of the antibody drug are continuing. The first results suggest that it could help eliminate the coronavirus earlier and possibly reduce hospitalizations in people with mild to moderate COVID-19. A study in hospital patients was stopped when independent monitors saw that the drug did not seem to help in this situation.
The government had previously made a deal to purchase and supply much of Lilly’s initial drug production.
Only one drug – Gilead Sciences’ remdesivir – has full FDA approval to treat COVID-19. Government treatment guidelines also support the use of dexamethasone and other steroids for some critically ill and hospitalized patients.
Another treatment now has an emergency use designation: convalescent plasma, or blood from COVID-19 survivors. However, no large study has shown it to be more effective than usual care alone.
The new drug is part of an emerging family of biologic therapies that offer a promising new approach to prevent serious illness 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.
Drugs are lab-made versions of antibodies, proteins in the blood that the body creates to help target and clear foreign infections. The new therapies are concentrated versions of the antibodies that have been shown to be most effective against the virus in patient studies.
Regeneron Pharmaceuticals Inc. has also requested emergency clearance for an antibody it is testing – the drug Mr Trump received.
FDA regulators have cleared the drug Lilly to use their emergency powers to accelerate the availability of investigational drugs and other medical products during public health crises.
Normally, the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, tightly controlled patient studies. But during public health emergencies, the agency may lower those standards and only require that the potential benefits of an experimental treatment outweigh its risks.
The emergency clearance works as a temporary approval for the duration of the COVID-19 pandemic. To gain full approval, Lilly will need to submit additional research to fully define the drug’s safety and benefits for patients.
The government signed an agreement with Lilly to spend $ 375 million to purchase 300,000 vials of the drug. The number of doses that would provide is not clear.
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