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Independent consultant will review Lilly’s COVID-19 plant issues

COVID-19 antibody trial was paused last week due to safety issue

Eli Lilly has said it has hired an independent consultant to review systems at is New Jersey, US manufacturing plant, where it’s investigational COVID-19 antibody is being manufactured.

Last week, Lilly paused a clinical trial of its COVID-19 antibody treatment due to a potential safety concern. At that time, an independent data safety monitoring board (DSMB) recommended that Lilly pause enrolment of the ACTIV-3 study.

The study had been evaluating Lilly’s investigational neutralising antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalised patients, and is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID).

Reuters reported that US Food and Drug Administration (FDA) has previously discovered ‘serious quality control issues’ at the Lilly manufacturing plant in Branchburg, New Jersey last year.

Inspectors found last November that data had been deleted from previous manufacturing processes, which resulted in an ‘Official Action Indicated’ notice being issued.

In a statement released yesterday, Lilly reconfirmed that it had received the OAI notice, adding that the issues raised during the inspections have its ‘full attention’.

The company added that it has been working closely with the FDA to remedy the issues, but maintained that it had not received a warning letter or other enforcement letter from the agency related to the quality control issues.

The Branchburg site is among several worldwide Lilly plants currently producing bamlanivimab, one of the company’s COVID-19 neutralising antibodies.

“We are confident in the quality systems for our global manufacturing processes. Our commitment to the safety of our medicines has not – and will not – change during our efforts to provide treatments to fight this global pandemic,” Lilly added in its statement.

Regeneron, which is also developing an antibody treatment for COVID-19, said that it is seeking emergency use authorisation from the FDA for its therapy last week.

Last month, Regeneron released data from the first descriptive analysis of REGN-COV2, in which the treatment demonstrated the ability to reduce viral load and speed up recovery time in non-hospitalised COVID-19 patients.

The promising results came from a large programme investigating REGN-COV2 in non-hospitalised COVID-19. Regeneron is also investigating the cocktail as a treatment for hospitalised COVID-19 patients and for the prevention of infection on people who have been exposed to the virus.

Regeneron said in a statement that currently, there are REGN-COV2 doses available for approximately 50,000 patients, with Regeneron expecting to have doses available for another 300,000 patients in total within the next few months.

Article by
Lucy Parsons

21st October 2020

From: Regulatory



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