CLAIM #6140 · Amgen Inc (AMGN) · 2024Q4 earnings call · Feb 4, 2025 · due Jun 30, 2026
“we expect to initiate an additional Phase III outcome study in patients with elevated Lp(a) and at high risk for a first cardiovascular event late this year or in the first half of 2026.”
Jay Bradner · EVP, R&D
In context
“e II type 2 diabetes study and part 2 of the ongoing Phase II chronic weight management study. Beyond MariTide, in general medicine, we look forward to data from the Repatha VESALIUS Phase III primary prevention study in the second half of this year. Having demonstrated profound and sustained benefit of Repatha in the secondary prevention setting, we're excited about these data and the opportunity to reach additional patients at high risk of a first cardiovascular event. Turning to olpasiran, our promising best-in-class, small interfering RNA medicine targeting Lp(a), we are bringing a precision medicine to cardiovascular risk reduction for the many individuals with Lp(a) elevation. The fully enrolled OCEAN(a) Phase III cardiovascular outcomes trial of olpasiran continues to progress, and we expect to initiate an additional Phase III outcome study in patients with elevated Lp(a) and at high risk for a first cardiovascular event late this year or in the first half of 2026. Shifting to rare disease. We are very excited about UPLIZNA's potential to serve even more patients facing rare inflammatory illnesses. In 2024, we generated compelling data from the UPLIZNA Phase III MITIGATE study in patients with IgG4-related disease, a serious inflammatory condition with no approved therapies. These data are now under FDA priority review with a PDUFA date of April 3, 2025. The FDA also granted orphan drug designation to UPLIZNA for the treatment of generalized Myasthenia Gravis based upon 26-week data from the Phase III MINT study. This study showed UPLIZNA to be highly effective on multiple clinical outcomes, also reducing the need for steroids with patient-centered convenient dosing. We eagerly anticipate the 52-week data later this year, which will provide further”
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SEC filings for AMGN ↗ · Claim quote is verbatim from the 2024Q4 earnings call.