The FDA recently rejected Eli Lilly’s biologic license application (BLA) for their anti-interleukin (IL) -23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). This news will likely delay mirikizumab’s entry into the US market as it will inevitably fall behind competitors, which are aiming to enter the UC market during 2021-31, says GlobalData, a leading data and analytics company.

Ramla Salad, Pharma Analyst at GlobalData, comments: “GlobalData anticipated mirikizumab to be approved in the US in 2023, but this recent development may push mirikizumab back behind other agents such as AbbVie’s Skyrizi and Janssen’s Tremfya, which are anticipated to enter the US market in 2024 and 2025, respectively. GlobalData estimates Stelara to reach sales of $525.5 million in the US in 2031 and mirikizumab to reach sales of $318.2 million in 2031.”

Key opinion leaders (KOLs) interviewed by GlobalData mentioned that mirikizumab did have potential; many of them highlighted the selectivity it offers and the option it provides for patients who do not respond to Stelara.

Salad continues: “The selective inhibition of IL-23 inhibitor therapies such as mirikizumab is seen as a key advantage over Stelara, a therapy that targets both IL-12 and IL-23. The selective mechanism of action of IL-23 inhibitor therapies is one that will help these agents differentiate themselves in the crowded biologics space for UC.”

Despite the recent setback, it is worth noting that mirikizumab has already been approved in Japan for the treatment of adults with moderate to severe UC. Additionally, the IL-23 inhibitor also received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) as a first-in-class treatment for adults with moderately to severely active UC.

Salad concludes: “As the FDA has raised no concerns with the clinical profile of mirikizumab, Lilly could still stage a comeback with this agent as the first-to-market IL-23 inhibitor therapy for UC in the US. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns. Lilly is also investigating mirikizumab in Crohn’s Disease; so, this hold up could help inform Lilly of future decisions to avoid further delays in the approval process.”