Eli Lilly, which had set ambitious plans to introduce four new drugs in 2023, has faced another setback on the regulatory front. The FDA has declined approval for Lilly’s investigational treatment for atopic dermatitis, lebrikizumab, citing issues discovered during an inspection of a third-party contract manufacturing organization. This recent development marks the third rejection for Lilly this year.
However, it’s important to note that the FDA’s complete response letter (CRL) did not raise concerns about lebrikizumab’s clinical data or its safety and labeling. Furthermore, this setback does not affect any of Lilly’s other medications.
Patrick Jonsson, Lilly’s Executive Vice President and President of Lilly Immunology and Lilly USA, expressed the company’s commitment to addressing the feedback received from the FDA and working closely with the third-party manufacturer to eventually make lebrikizumab available to patients. Lebrikizumab was among the key drugs that Lilly had hoped to launch in 2023, alongside donanemab, pirtobrutinib, and mirikizumab, all of which were anticipated to be major drivers of growth, along with the diabetes medication Mounjaro, launched in 2022.
These launch plans were part of Lilly’s broader revenue expectations for 2023, ranging between $30.3 billion and $30.8 billion.
Nonetheless, the rejection of lebrikizumab is the third such setback for Lilly this year, following earlier rejections of mirikizumab for ulcerative colitis and donanemab for the treatment of Alzheimer’s disease. In April, manufacturing issues were identified by the FDA with regards to mirikizumab, prompting Lilly to collaborate with the agency to address these concerns. Prior to that, in January, the FDA declined to grant accelerated approval for donanemab in Alzheimer’s disease due to the limited number of patients exposed to the drug for at least 12 months in a clinical study.
Despite these challenges, Eli Lilly remains committed to its mission of delivering innovative treatments to patients, and the company’s shares experienced a slight decline of approximately 0.45% in Monday morning trading following the news about lebrikizumab.