Lilly pauses COVID-19 antibody trial after factory hits trouble with FDA
Eli Lilly has put a clinical trial of its COVID-19 antibody therapy on hold after FDA inspectors found serious quality control problems at the plant, according to press reports.
The decision could spell trouble for Lilly’s attempts to get the FDA to grant the antibody therapy an Emergency Use Authorisation (EUA).
Lilly’s EUA is based on data from a smaller clinical trial but the data from the halted phase trial, ACTIV-3 could be used to support a full authorisation in the longer term.
Like a rival from Regeneron that could also be granted an EUA, Lilly’s antibody therapy LY-CoV555 works by neutralising the virus once it has begun to infect a patient.
President Donald Trump has hailed these antibody therapies as potential “cures” for the disease, although Regeneron has stressed that evidence is not there to support this claim.
Citing three sources close to the matter, Reuters reported that FDA officials found standards at the plant in Branchburg, New Jersey below requirements.
The inspectors found last November that data on the plant manufacturing processes had been deleted and not properly audited according to the sources who asked to remain anonymous.
Eli Lilly has not commented directly on the matter but said in a statement that it had paused the ACTIV-3 trial testing the drug out of “an abundance of caution” on the recommendation of its data safety monitoring board.
Indianapolis-based Lilly wants the drug to be tentatively approved for use in higher-risk patients who have been recently diagnosed with COVID-19.
It is asking first for an EUA for a monotherapy antibody therapy and plans to follow this with a similar application for a combination therapy next month.
This is the second COVID-19 trial to hit trouble in the space of a day – Johnson & Johnson has stopped a trial of its potential vaccine after a subject developed an unexpected illness.
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