After laying out a goal to launch four new drugs in 2023, Eli Lilly has run into yet another regulatory snag.
The FDA has rejected Lilly’s investigational atopic dermatitis treatment lebrikizumab over findings uncovered during an inspection of a third-party contract manufacturing organization, Lilly said Monday.
The agency’s complete response letter (CRL) raised no issues with lebrikizumab’s clinical data package, nor did the FDA flag problems with the med’s label or safety, Lilly said in a release. Further, no other Lilly drugs are affected by the poor inspection outcome.
"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,” Patrick Jonsson, Lilly executive vice president and president of Lilly Immunology and Lilly USA, said in a statement.
Lebrikizumab was one of several new drugs Lilly hoped to launch in 2023. During an investor event last winter, Lilly pegged expected 2023 launches of donanemab, pirtobrutinib, mirikizumab and lebrikizumab as major growth drivers, along with its 2022 diabetes launch Mounjaro.
Alongside those launch plans, Lilly laid out revenue expectations of between $30.3 billion and $30.8 billion for 2023.
But lebrikizumab marks Lilly’s third rejection this year, following slapdowns of mirikizumab for ulcerative colitis and donanemab for the treatment of Alzheimer’s disease.
In April, the FDA identified issues pertaining to mirikizumab’s manufacturing. In a statement at the time, a Lilly spokesperson said the company was working with the FDA to “address and resolve observations” that were noted during a pre-approval inspection.
Prior to that rejection, the FDA in January declined to grant donanemab an accelerated approval in Alzheimer’s disease. The FDA rejected the company's filing due to the limited number of patients who had seen at least 12 months of drug exposure in a clinical study, according to the company. The agency did not flag any other issues.
After the lebrikizumab news, Lilly’s shares were down about 0.45% in Monday morning trading.