- The Food and Drug Administration has rejected an experimental Eli Lilly drug for eczema, citing findings from a manufacturing inspection, according to a Monday statement from the pharmaceutical company.
- Lilly said the FDA’s complete response letter didn’t flag any issues with clinical data for the drug, called lebrikizumab. The manufacturing issues were revealed in a “multi-sponsor” inspection of a contract manufacturer that Lilly uses to produce the drug substance for lebrikizumab.
- Acquired by Lilly in 2020, lebrikizumab is designed to treat moderate-to-severe atopic dermatitis. If approved, it would compete with Sanofi and Regeneron Pharmaceuticals’ blockbuster drug Dupixent.
Lilly bet on lebrikizumab when it bought the drug’s owner Dermira for $1.1 billion. At the time of the buyout, Phase 3 testing had just begun on the antibody treatment, which works by binding to a cytokine called IL-13.
Clinical data have been positive, showing treatment could help clear up patients’ skin. Lebrikizumab could also hold a dosing advantage over Dupixent, which initially requires two subcutaneous injections followed by an injection every two or four weeks.
“We really believe that we are positioned to launch a first-line biologic that actually has less frequent dosing than Dupixent,” said Patrik Jonsson, head of Lilly’s immunology division on a second quarter earnings call.
But the complete response letter will put those plans on hold. Akash Tewari, an analyst at Jefferies, estimates that resolving the issues, resubmitting and securing an approval could take Lilly eight to 12 months.
“We will continue to work closely with the third-party manufacturer and the FDA to address the feedback in order to make lebrikizumab available to patients,” Jonsson said in Lilly’s Monday statement.
The rejection adds to a string of manufacturing issues for Lilly. One of its factories, a site in New Jersey, has been under scrutiny since 2019. Recently, the company settled a whistleblower lawsuit in which a former employee alleged she was let go after calling attention to poor manufacturing procedures — a claim Lilly denied.
And earlier this year, Lilly received a complete response letter for an ulcerative colitis drug called mirikizumab that was also related to manufacturing. While the company didn’t specify the problems, one Wall Street analyst speculated that problems were uncovered in a pre-approval inspection of a site in Indianapolis.
Mirikizumab is one of Lilly’s most anticipated launches and is projected to bring in billions of dollars in revenue alongside the diabetes treatment Mounjaro and the experimental Alzheimer’s drug donanemab. A biologic injection, mirikizumab blocks a specific part of a protein called IL23p19 and could be the first of its kind approved for ulcerative colitis.
Lilly resubmitted an approval application for mirikizumab in the second quarter of 2023.
Shares in the company fell by 1% in Monday morning trading.