Eli Lilly’s tirzepatide results demonstrating better A1C and body weight reductions from baseline in type 2 diabetes (T2D) patients caused its Likelihood of Approval (LoA) score to increase by 7 points, as of 24 May.
The company announced positive topline results from the Phase III SURPASS-4 study, which is one of the five registrational studies for tirzepatide’s use in T2D, on 20 May. Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist. The drug recorded an A1C reduction at 52 weeks from baseline, the trial’s primary endpoint, of 2.58% at its highest dose of 15 mg compared to 1.44% for those treated with insulin glargine. Moreover, tirzepatide also reduced participants’ body weight by 11.7 kg while those on the comparator arm saw a weight gain of 1.9kg. Lilly now plans to submit a complete approval application for tirzepatide by YE21, as per the same release.
The SURPASS-4 study was specifically intended for T2D patients with increased cardiovascular risk factors, and it was completed once a predefined number of major adverse cardiovascular events (MACE) was accrued. A pooled analysis of participants with MACE-4, a composite score of death due to cardiovascular or undetermined causes, myocardial infarction, stroke, and hospitalisation for unstable angina, across tirzepatide clinical trials was done and the majority of cases were derived from the SURPASS-4 trial. The cardiovascular safety meta-analysis indicated that tirzepatide use versus comparator treatments was associated with a hazard ratio of 0.81.
As per Lilly, tirzepatide represents a new drug class to treat T2D, and it is estimated to earn $4.04bn in global sales in 2027, as per GlobalData consensus forecasts. Eli Lilly’s market cap is $191.83bn. The LoA score which is calculated by GlobalData’s analysis, uses a combination of machine learning and a proprietary algorithm. While prior to this news, the LoA score was 48%, it is now at 55%.
Manasi Vaidya is a Associate Editor for Pharmaceutical Technology parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.