“We are initiating multiple Phase 3 studies including in secondary prevention; intermediate to high-risk primary prevention; and for patients with heterozygous familial hypercholesterolemia.”

In context

“ng or death versus placebo. These findings were published simultaneously in the New England Journal of Medicine. We are working diligently to submit filings from the STELLAR data to regulatory agencies and at this time, anticipate filing in the U.S. in the third quarter of this year followed by the EU. We are advancing the broad sotatercept program, including the HYPERION, ZENITH, SOTERIA and Phase 2 CADENCE trials which are actively recruiting. Also at the ACC meeting, detailed Phase 2b results for MK-0616 were presented showing a reduction of LDL-cholesterol levels from 41.2 up to 60.9% versus placebo. Up to 90% of patients receiving MK-0616, at the highest dose studied, were able to reach their LDL-C goal. An oral PCSK9 inhibitor could provide the opportunity for broad, global access. We are initiating multiple Phase 3 studies including in secondary prevention; intermediate to high-risk primary prevention; and for patients with heterozygous familial hypercholesterolemia. In parallel, we will conduct a cardiovascular outcomes trial. We are making progress towards our goal of developing medicines that improve and extend the lives of patients with cardiovascular diseases and look forward to providing updates in the future. Turning to oncology. As I have mentioned previously, a key area of focus and execution has been the development of treatments for earlier stages of cancer where there remains significant unmet need. We announced FDA acceptance of our application for KEYTRUDA in combination with platinum doublet chemotherapy as neoadjuvant, followed by adjuvant therapy in patients with resectable stage II, IIIA and IIIB non-small cell lung cancer, based on the findings to date from the KEYNOTE-671 study. The Agency has set a PDUFA action date of October 16”