Just days after Eli Lilly sent an COVID-19 antibody ahead for FDA scrutiny, the drugmaker’s immediate chances were halted by a damaging trial stop for the therapy. Now, the FDA has knocked Lilly for its manufacturing controls at a New Jersey site producing the antibody.
The FDA cited Lilly’s Branchburg, New Jersey, facility on two counts of inadequate “control of computer systems,” Lilly confirmed in an email. Those two findings included deleted data on the company’s manufacturing processes and failed quality control over audit paper trails, sources told Reuters.
While Lilly assured that the flaws weren’t tied to its production of COVID-19 antibody LY-CoV555, which is produced on site, the findings could complicate the therapy’s bid for an emergency use authorization.
After an inspection in November, FDA investigators flagged the quality control deficiencies in a notice sent to Lilly, the drugmaker said. The investigators’ findings qualified as official action indicated (OAI) in the notice, the highest enforcement priority level from the FDA for its observations.
In response, Lilly drafted a remediation plan and has been “working aggressively to resolve the issues identified,” including hiring an external consultant and bringing on more workers to offset an increased workload tied to production of active pharmaceutical ingredients (APIs).
The drugmaker hasn’t received any further enforcement notices or warning letters from the FDA and said the findings haven’t hit its API supplies.
Lilly’s Branchburg plant not only flopped its FDA inspection, but on-site workers had already warned company officials about the issues before the walk-through, according to Reuters sources. Those complaints reportedly centered on understaffing and falsified records.
However, Lilly contended the FDA found no evidence of falsified records during its inspection. The deletions cited in the Reuters report were tied to “equipment set up activities prior to use,” Lilly said, and not actual manufacturing runs.
“At no point was data deleted that was related to an actual production run and there has been no impact on product quality or safety,” a Lilly spokeswoman said.
The FDA’s hammer drop comes as a one-two punch to Lilly’s chances at an emergency nod for LY-CoV555 after the National Institutes of Health (NIH) halted a late-stage trial for the antibody Tuesday.
The trial’s independent data safety monitoring board recommended the company pause enrollment, a Lilly spokesperson told CNBC in an email Tuesday, adding, “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”
The news comes one day after Johnson & Johnson paused a phase 3 study for its COVID-19 vaccine because a patient had an “unexplained illness”—and about a month after AstraZeneca suspended a trial for its COVID-19 jab because a patient developed transverse myelitis, a type of spinal cord inflammation that can be triggered by infections.
It also comes 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.
Lilly is one of two drugmakers chasing an emergency authorization for its COVID-19 antibody; Regeneron sent its antibody cocktail REGN-COV2 ahead for FDA scrutiny last week, after it was used to treat President Donald Trump.
Regeneron’s therapy comes with immense hype after Trump’s treatment. Since his release from Walter Reed Medical Center earlier this month, Trump has called the unapproved therapy a “cure,” though Regeneron CEO Len Schleifer, M.D., Ph.D., has said the drugmaker is still chasing large-scale clinical data to back its use.
With either drug a potential winner with regulators, experts have warned the industry has not done enough to build manufacturing capacity for antibodies, which are expensive to produce and distribute. Sunday, former FDA Commissioner Scott Gottlieb. M.D., warned that drugmakers were “too late” to meet U.S. demand this year and would likely only start to keep up in 2021.
Editor’s note: This story has been updated to include comments from Eli Lilly.