USFDA revokes authorization of COVID antibody drugs of GSK, Lilly and 2 others
The US Food and Drug Administration (USFDA) has revoked the emergency use authorisation for four Covid-19 antibody-based drugs from pharma giants, citing expired shelf lives.
The revoked drugs include Eli Lilly's bebtelovimab, AstraZeneca's Evusheld, GSK's sotrovimab and Regeneron's REGEN-COV, as per Reuters reported.
In a letter dated earlier this month and posted on its website on Monday, FDA said, the shelf life of the drugs had expired and they had not been authorized for administration to patients for more than a year due to the circulation of non-susceptible variants.
The companies also do not intend to offer the products in the US anymore, according to the FDA.
The FDA said the companies would notify customers and providers about the revocation with instructions for product destruction or return.
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Medical Dialogues team had earlier reported that USFDA had added a boxed Warning highlighting the known risk of rare but serious liver injury associated with use of menopause medicine Veozah (fezolinetant). VEOZAH is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
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