Please ensure Javascript is enabled for purposes of website accessibility

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

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

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

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.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Eli Lilly and Company Stock Quote
Eli Lilly and Company
LLY
$365.25 (0.98%) $3.53
Gilead Sciences Stock Quote
Gilead Sciences
GILD
$86.26 (0.98%) $0.84

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
356%
 
S&P 500 Returns
118%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 11/28/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.