SAN FRANCISCO — For months, drugmakers have been pleading with regulators to lower the bar for authorizing antibody drugs for Covid.
The virus, they noted, had evolved fast enough to render every previous antibody obsolete. Any new antibody may only survive a few months or a year before variants evade it — too fast for a company to profit and potentially too fast to manufacture and test the drug in clinical trials before it goes extinct.
So companies have been asking the Food and Drug Administration to adopt a strategy similar to the one it adopted for vaccines and allow drugs on the market after just lab studies and safety human trials. After all, there are still millions of immunocompromised people in the U.S. who could use additional protection and treatment if they do get sick and who, with the latest variants, have no options available today.
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