BioPharma, Pharma

FDA Rejects Eli Lilly Ulcerative Colitis Drug Over Manufacturing Issues

Rejection of Eli Lilly’s mirikizumab means that two of the four drugs the pharma giant identified as revenue growth drivers for 2023 have failed to pass the regulatory bar. One of those drugs has been approved while the fourth drug still awaits an FDA decision.

An Eli Lilly ulcerative colitis drug that the company singled out as one of four expected product launches for this year has been rejected by the FDA. According to the company, the regulator cited manufacturing issues.

Complete response letters are not public documents and the manufacturing problems were not specified. The Indianapolis-based drug giant said Thursday that no issues were raised about the clinical data, safety, or the label of the drug, mirikizumab. Lilly sees potential applications for the drug beyond ulcerative colitis. It is also in late-stage development for Crohn’s disease.

Rejections due to manufacturing problems are common, particularly for complex biological drugs like mirikizumab. The drug is a monoclonal antibody designed to block interleukin 23, or IL-23, a signaling protein associated with inflammation, such as the gut inflammation characteristic of ulcerative colitis. In Phase 3 testing, Lilly had reported that half of patients treated with the drug achieved clinical remission, defined as control or resolution of colon inflammation, at one year.

“We remain confident in mirikizumab’s pivotal Phase 3 clinical data and its potential to help people with ulcerative colitis,” Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer, said in a prepared statement. “We are working diligently with the FDA and hope to launch mirikizumab in the U.S. as soon as possible.”

Lilly said that mirikizumab recently won regulatory approval in Japan for treating adults with moderate-to-severe active ulcerative colitis. The drug is still under review in Europe, and Lilly expects additional regulatory decisions in other markets later this year.

Manufacturing issues can be resolved, but at best they mean a delay for Lilly’s commercialization plans. The FDA rejection of mirikizumab is a setback for the drug and for Lilly’s financial goals. When the pharma giant issued its 2023 financial guidance, the company highlighted the potential approval and launch of up to four new drugs as expected revenue drivers. So far, just one has secured approval: mantle cell lymphoma drug pirtobrutinib, brand name Jaypirca.

The Jaypirca approval followed the rejection of the accelerated approval application for Alzheimer’s drug donanemab. The FDA concluded Lilly’s submission did not have data from enough patients. Lilly said data from an ongoing Phase 3 study will be incorporated into an application seeking traditional FDA approval, which likely pushes the regulatory review timeline into 2024.

The fourth drug that Lilly singled out, lebrikizumab, is an antibody drug designed to target a protein called IL-13 to treat atopic dermatitis. Lilly submitted a biologics license application for that drug candidate last fall.

Photo by Flickr user Ed Uthman via a Creative Commons license