Mirikizumab, a monoclonal antibody (mAb) targeting the p19 subunit of IL-23, was approved as first-in-class therapy for ulcerative colitis by the EMA and the U.S. FDA and will likely be the third in the class approved for Crohn’s disease. Included in Drugs to Watch 2023, a delayed U.S. launch due to manufacturing concerns by the U.S. FDA meant that it remained a drug to watch for 2024.
Part of a set of emerging therapies with novel mechanisms of action, it will contribute to the growing market share held by these therapies and potentially more efficacious and long-lasting treatment options for patients.
March 2022
March 2023
For adult patients with moderately to severely active ulcerative colitis not well controlled with standard therapy
April 2023
For issues related to the proposed manufacturing
May 2023
For adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to or were intolerant to either conventional therapy or a biologic treatment
June 2023
For adult patients with moderately to severely active ulcerative colitis
October 2023
For adult patients with moderately to severely active ulcerative colitis
Actual and expected launch:
Patents estimated to expire beginning in 2034
How will mirikizumab impact the market for Crohn’s disease and ulcerative colitis?
What gaps in treatment does mirikizumab fill?
Both Crohn’s disease and ulcerative colitis are characterized by intermittent disease courses, with acute flares followed by periods of remission. Patients risk hospitalization and the need for surgical intervention, in addition to experiencing poorer quality of life. Neither disease has a cure, so pharmacotherapy aims to induce remission of acute flairs, maintain remission (without corticosteroids) and improve quality of life. Treatment gaps that mirikizumab could help fill include sustainable long-term remission (many patients lose response to biologics) and therapies with alternative mechanisms of action for patients intolerant or resistant to TNF-α inhibitors.
What hurdles might it need to overcome to reach blockbuster status?
The later market entry of mirikizumab, after STELARA and other IL-23 inhibitors, for both Crohn’s disease and ulcerative colitis, will likely restrain its uptake. Regarding STELARA, gastroenterologists will have had 6-8 years of clinical experience prescribing it, and at least initially, new IL-23 inhibitors are unlikely to steal significant patient share and could be used primarily as later-line therapies. In addition, the launch of biosimilar ustekinumab, which is expected in 2023, could encroach on the use of all IL-23 inhibitors. Unless it shows significantly greater safety and efficacy, mirikizumab will be one of many therapeutic options in an increasingly crowded space.
– Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates Prediction current as of November 3, 2023
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