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More Good COVID News From the Pharma Industry

Eli Lilly's antibody drug gets emergency use approval
By Evann Gastaldo,  Newser Staff
Posted Nov 10, 2020 3:40 AM CST

(Newser) – On the same day Pfizer announced its big news on the coming coronavirus vaccine, more positive news from the pharmaceutical industry: Eli Lilly's experimental antibody drug has been given the green light by the FDA. Bamlanivimab, the first such drug to help the immune system fight COVID-19, is now allowed for emergency use, the AP reports. It's the first treatment authorized for those with earlier-stage infections who are not hospitalized, filling what the Wall Street Journal calls a "gap in treatment." The one-time IV treatment can be given to anyone 12 and up with mild to moderate symptoms that have not required hospitalization, but who are at high risk of moving to more severe symptoms. A study showed that while the drug helped improve symptoms and often kept patients out of the hospital, it had no clinical benefit for those already hospitalized.

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The treatment is similar to the one by Regeneron that President Trump received after contracting the coronavirus; Regeneron has also requested emergency authorization and says it's in discussions with the FDA. So-called monoclonal antibodies are designed in labs to mimic the antibodies the immune system produces to fight the virus, and Eli Lilly's are derived from antibodies isolated in the blood of COVID-19 patients who recovered. The therapy is still being tested to determine safety and effectiveness, but in emergency situations, the FDA needs only determine a drug's benefits outweigh its risks to grant such authorization. One other treatment, the use of convalescent plasma (the blood of survivors) also has emergency authorization; just one drug, remdesivir, has full FDA approval, and doctors can also use steroids for certain patients. (Read more coronavirus stories.)

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