Biotech executives and a handful of academics pleaded with U.S. and European regulators on Thursday to adopt new standards for approving antibody drugs against Covid, particularly for immunocompromised and other vulnerable patients.
The four-hour hearing came as agencies, companies, and researchers face a fundamental mismatch: The virus is evolving faster than our ability to develop interventions under normal — or even normal emergency — procedures.
The Food and Drug Administration pulled the last remaining antibody treatment, bebtelovimab, last month in the face of a swarm of new variants. Evusheld, the long-acting antibody used to protect cancer patients, transplant recipients, and others who don’t respond fully to vaccines, is still authorized but unlikely to provide much benefit.
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