Eli Lilly's chances at an emergency use authorization for a COVID-19 antibody took a big hit after a major trial was stopped for safety concerns and the FDA flagged problems at a manufacturing site producing the therapy. Now, the FDA is back for more, and it could spell even bigger problems.
Lilly could face an FDA warning letter after a follow-up inspection at the plant that showed "a major failure of quality assurance," sources told Bloomberg. Located in Branchburg, New Jersey, the site is manufacturing Lilly's COVID-19 antibody LY-CoV555, among other drugs.
An FDA warning letter, which signals continuing deficiencies at a drug manufacturing plant, would escalate the current "official action indicated" notice Lilly received for a previous FDA inspection at the site in November 2019.
In that notice, the FDA cited Lilly on two counts of inadequate "control of computer systems," the drugmaker confirmed last week. The agency cited the plant for improperly deleting data on its manufacturing processes and failing to review quality-control audits, sources told Reuters.
Despite that earlier citation, FDA inspectors again found problems at the plant in August, Bloomberg reported, and is asking the agency to "take action." The Branchburg site is one of five that produce the antibody, Lilly said in a Tuesday statement, and the FDA has yet to issue a warning letter to the drugmaker.
In response to the FDA's findings in November, Lilly has added staff at the Branchburg site and hired an external consultant to review its data handling, the company said.
While Lilly maintains that the shortfalls flagged by the FDA haven't affected the quality of its antibody, which the agency is reviewing for an emergency authorization, sources painted a different picture for Bloomberg.
Compliance officers conveyed one incident in which a Lilly employee used the wrong material in a "crucial" purification process, Bloomberg said. Employees also reportedly retested samples for impurities to get back a positive result and denied FDA investigators' requests to review human resources documents related to potential data handling citations.
A Lilly spokesman refused to comment in an email on the specific allegations in the Bloomberg report, saying the company was "not in receipt of any of the documents referenced by Bloomberg and thus cannot confirm their authenticity."
The Branchburg site also produces migraine med Emgality, and Lilly has requested FDA authorization to produce GLP-1 diabetes med Trulicity on-site as well, Bloomberg said.
Potential quality issues for Lilly's antibody come as an ill omen after the National Institutes for Health halted a phase 3 study of the therapy earlier this month on safety concerns.
The trial's independent data safety monitoring board recommended the company pause enrollment, a Lilly spokesperson told CNBC in an email, adding, “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study."
The trial halt came just days after Lilly asked the FDA to clear LY-CoV555 for emergency use based on phase 2 data showing it cut the rate of hospitalizations in patients recently diagnosed with mild to moderate COVID-19. However, two of the three doses tested in the study failed to beat placebo in terms of reducing viral load by the 11-day mark.