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Eli Lilly's COVID-19 Treatment Candidate Has a Manufacturing Site Problem

By Cory Renauer – Oct 14, 2020 at 10:48AM

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FDA inspectors last year noted issues at a manufacturing site now being used to produce the monoclonal antibody LY-CoV555.

Eli Lilly's (LLY 0.98%) COVID-19 roller-coaster ride took a turn for the worse on Wednesday morning. According to Reuters, the FDA found quality-control issues last year at a site currently being used to manufacture LY-CoV555, a monoclonal antibody that attaches itself to the coronavirus responsible for COVID-19 before it can enter host cells and turn them into virus-replicating factories.

Following an inspection last November, the FDA found data regarding manufacturing processes that had been deleted without an appropriate audit from the company's quality-control unit. While these recently highlighted issues don't concern LY-CoV555 directly, they did result in an "Official Action Indicated" notice from the FDA that hasn't yet been resolved. As such, they could lead to a delay in LY-CoV555 receiving emergency use authorization because it was manufactured on the same site.

Person working in a laboratory.

Image source: Getty Images.

On Tuesday, the National Institutes of Health (NIH) pumped the brakes on a clinical trial testing LY-CoV555 in combination with Gilead Sciences' (GILD 0.98%) antiviral drug remdesivir due to potential safety concerns. The study randomized patients to receive remdesivir plus either LY-CoV555 or a placebo. It's unclear at this point which medicine being tested was responsible -- or if either of them were.

The NIH study, which began on Aug. 4, is expected to enroll around 10,000 hospitalized COVID-19 patients through 51 locations. With such a large population of hospitalized patients, there's a good chance the NIH's decision to pause the study wasn't related to an unresolved issue regarding a different drug at LY-CoV555's manufacturing site.

On Oct. 7, Eli Lilly sent a request to the FDA for emergency use authorization for LY-CoV555 based on some compelling clinical trial results that suggest the benefits it provides outweigh any apparent risks. 

Cory Renauer owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool has a disclosure policy.

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