March 24, 2023
Eli Lilly Poised to Nab First to Market Advantage with it’s IL-23 Inhibitor Mirikizumab in Ulcerative Colitis, Creating an Opportunity to Build a Loyal Base Ahead of AbbVie and Janssen’s Respective IL-23 Entries, According to Spherix Global Insights
Gastroenterologists project mirikizumab will play a significant role in the treatment of ulcerative colitis
Exton, PA., March 15, 2023 – In 2021, Eli Lilly (“Lilly”) announced it would forego pursuing a psoriasis indication for it’s IL-23 inhibitor mirikizumab, strategically focusing instead on the inflammatory bowel disease (IBD) market. The decision created an opportunity to deliver the first indicated IL-23 inhibitor to the Ulcerative Colitis (UC) market. With an anticipated FDA decision just days away, the market is set to test how Lilly’s decision will pay off should mirikizumab be approved.
Mirikizumab is Lilly’s first advanced treatment to enter the gastroenterology space. Leading into the launch, mirikizumab awareness among gastroenterologists is modest with roughly half reporting familiarity with the molecule and the vast majority stating it will play a significant role in the treatment of UC (Spherix RealTime Dynamix™ UC, Q1 2023).
Physicians speaking with Spherix about mirikizumab’s potential introduction were quoted as saying it “could rival Skyrizi as another option for patients with UC that might be more effective than current Stelara.”
Spherix further found the prominence of the IL-23 class has been bolstered in general through its use in adjacent immunology indications (e.g. psoriasis, psoriatic arthritis) as well as IBD specifically, with the June 2022 US approval of AbbVie’s Skyrizi (risankizumab) in Crohn’s Disease (CD). Gastroenterologists have doubled their initiations of Skyrizi each quarter since the Q3 2022 launch (Spherix Launch Dynamix™ – Skyrizi) cementing a positive impression of the IL-23 mechanism from which Lilly can build upon.
As the UC market becomes saturated and commoditized with additional branded and biosimilar agents, new entrants will likely have to compete for second line positions following entrenched or cheaper competitors. Only Entyvio (vedolizumab) with its head-to-head VARSITY trial (vs. Humira) in UC has managed to contend with the blockade of first-line anti TNF treatments. Lilly’s best chance to establish a substantial footprint ahead of AbbVie and Janssen’s IL-23 agents (risankizumab & guselkumab) will be displacing second-line therapies – an aspect even Skryrizi is actively working to achieve in CD. Indeed, while Skyrizi garnered an impressive switch share in CD just months after launch, missed opportunity analysis from Spherix’s RealWorld Dynamix™: Biologic and JAK Switching in IBD, 2022 audit reveals that the brand was in the running to double their switch-share, but was ultimately passed over for more established agents.
Results from mirikizumab’s LUCENT 1 trial can help influence physician prescribing in the second-line position. Outcomes published on Lilly’s medical information page show subgroups of patients who had previously failed a biologic or tofacitinib, achieved clinical remission at week 12 for 15.2% for patients who received mirikizumab vs. 8.5% of patients who received placebo. Such data align well with Spherix’s switching drivers analysis highlighting efficacy concerns as a primary trigger for switching (RealWorld Dynamix™: Biologic and JAK Switching in IBD, 2022).
Lilly will also introduce a novel secondary endpoint of reduced bowel urgency which may help drive mirikizumab use earlier in the treatment pathway. Spherix testing of the endpoint shows nearly all gastroenterologists found reduced bowel urgency either very or moderately influential when choosing a UC therapy (RealTime Dynamix™: UC, Q3 2022).
Lilly will likely have up to a year to establish a lead before a second IL-23 agent enters the UC market. With strong clinical evidence and well established IL-23 experience in Crohn’s established by AbbVie, the strategic opportunity Lilly created with their decision to arrive first to the UC market may very well poise them for success in this crowded market. Spherix will track mirikizumab performance through the first 18 months post approval through its Launch Dynamix™ service.
About Launch Dynamix™
Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.
About RealTime Dynamix™
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.
About RealWorld Dynamix™
RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.
About Spherix Global Insights
Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company’s unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.
A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology.
Spherix Global Insights Contacts
Geoff Red, Franchise Leader, Gastroenterology
Scott Upham, Corporate Communications
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