In recent years, with the advent of biologics and novel therapeutic targets such as anti-TNF, anti-interleukin, and anti-integrin, there has been a steady increase in the number of agents approved to treat inflammatory bowel diseases (IBD), which has provided physicians with an increasing number of options to treat Crohn’s disease (CD). However, this progress is not reflected with respect to approved treatments for paediatric IBD patients. Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014. Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients. This lack of options and progression within this IBD patient subpopulation presents a clear unmet need and opportunity.
The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs. Facing these challenges, many companies are incapable of evaluating therapies in children or adolescents, following approval for adults in the same intended indication. To address this problem, Eli Lilly and Janssen have formed a collaborative cross-company paediatric platform trial in paediatric IBD to establish a master protocol to help streamline the evaluation of the respective companies’ assets, mirikizumab and Tremfya (guselkumab), as described last September in the journal Therapeutic Innovation & Regulatory Science.1 Typically used to evaluate therapies in oncology, the use of master protocols may allow companies to streamline paediatric studies, and thereby make the approval of therapies more feasible.
If this collaboration, acting as a pilot study, is shown to accelerate the approval process, it may possibly salvage the mirikizumab program for Lilly. Mirikizumab has lost significant ground in the anti-IL23 drug class to AbbVie’s Skyrizi, and to a lesser extent Janssen’s Tremfya. In addition to Skyrizi’s recent supplementary CD indication, both Tremfya and Skyrizi received US FDA approval in psoriasis in 2017 and in 2019, respectively. These developments were compounded by Lilly’s announcement that it has discontinued development of mirikizumab for psoriasis in April of last year. If this new collaboration allows mirikizumab to enter the CD paediatric market before Skyrizi, then it will be a significant point of distinction that Lilly will use to separate from the rest of the drug class.
- Nelson RM, Conklin LS, Komocsar WJ, Chen F, Williamson F, Crandall WV. The Role of Master Protocols in Pediatric Drug Development. Ther Innov Regul Sci. 2022
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