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FDA clears emergency use of lab-made antibodies to treat COVID-19

It's a breakthrough for medical tech, if only for limited situations.
Unable to marshal the right cells and molecules to fight off the invader, the bodies of the infected instead launch an entire arsenal of weapons — a misguided barrage that can wreak havoc on healthy tissues, experts said. (Getty Images)
dowell via Getty Images
Jon Fingas
Jon Fingas|@jonfingas|November 22, 2020 12:52 PM

The FDA just cleared a medical advance that could play an important (if limited) role in treating COVID-19 patients. The administration has granted emergency use authorization for Regeneron’s lab-made monoclonal antibodies (a combo of casirivimab and imdevimab) to treat mild-to-moderate COVID-19 infections that are at “high risk” of developing into severe cases. Patients must be 12 years or older, but the FDA said the prime candidates were 65-plus or had some chronic medical issues.

The antibodies are proteins mimicking the immune system’s virus-fighting abilities. Regeneron’s cocktail is chiefly targeted at the new coronavirus’ spike protein, preventing it from attaching to cells and thus lowering the overall viral load. The treatment appears to be at least somewhat effective. Hospitalizations and emergency room trips were noticeably lower in test receipients than for a placebo group, at 3 percent versus 9 percent.

The agency stressed that this didn’t amount to full approval, and that there were distinct limits. There wasn’t evidence the antibodies helped already-hospitalized patients, and it might even lead to “worse clinical outcomes” for those who need high-flow oxygen or ventilators. Officials were still studying the effectiveness and safety of the treatment, the FDA said — the initial authorization came after the regulator determined that the known and likely benefits outweighed the risks.

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It’s hard to completely escape the politicization of the approval when President Trump was one of the earliest recipients of the antibodies and credited them with helping his recovery. As the FDA noted, though, there aren’t any other “adequate, approved and available” options for softening COVID-19’s blow. The lab-created antibodies could help save lives until there are widely available vaccines to limit the disease’s reach.

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