martes, 26 de marzo de 2024
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension List of authors. Marius M. Hoeper, M.D., David B. Badesch, M.D., H. Ardeschir Ghofrani, M.D., J. Simon R. Gibbs, M.D., Mardi Gomberg-Maitland, M.D., Vallerie V. McLaughlin, M.D., Ioana R. Preston, M.D., Rogerio Souza, M.D., Ph.D., Aaron B. Waxman, M.D., Ph.D., Ekkehard Grünig, M.D., Grzegorz Kopeć, M.D., Ph.D., Gisela Meyer, M.D., et al., for the STELLAR Trial Investigators*
https://www.nejm.org/doi/full/10.1056/NEJMoa2213558?utm_campaign=morning_rounds&utm_medium=email&_hsmi=299795638&_hsenc=p2ANqtz-9u_28Y3Ko3HP4m0hOxAV_oILeJWcoFMFi1ZAerXixccC_Pbul2e1hjcIHuLRb858D8niJx9dgobTyTr77cyLp5s2QMdA&utm_content=299795638&utm_source=hs_email
For people with a rare and deadly lung disorder called pulmonary arterial hypertension, treatment has meant measures to relax their blood vessels so it's easier for their hearts to pump blood into their lungs. Now the FDA is expected to approve a new drug from Merck that more directly targets the illness by blocking proteins known as activins that are involved in the growth of cells within the blood vessels.
Today’s decision follows a large trial published in the New England Journal of Medicine last year showing that the drug, called sotatercept, exceeded expectations in significantly increasing the distance that patients could walk and cutting their risk of death, worsening disease, and needing new treatments. The drug, given by injection every three weeks, does have a risk of bleeding so might be best suited at first for people at highest risk while longer-term data come in. STAT’s Elaine Chen has more.
With a potent new medicine, Merck marks a return to cardiology
Matthew Herper
By Matthew Herper March 6, 2023
https://www.statnews.com/2023/03/06/with-a-potent-new-medicine-merck-marks-a-return-to-cardiology/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=299795638&_hsenc=p2ANqtz-_BSMq7oxQ6X-DabtwI6jySNbHDmwjE6pFtUvd_AFHyW10BP1VOeFI6us-c2G9Ub95Q13larCNBBsNg7AUu1VhIJFMKcA&utm_content=299795638&utm_source=hs_email
Merck drug for rare, deadly lung condition appears set for approval in U.S.
Elaine Chen
By Elaine Chen March 26, 2024
https://www.statnews.com/2024/03/26/merck-sotatercept-lung-hypertension-fda-approval/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=299795638&_hsenc=p2ANqtz--jA_xmMNVy1aX4JcX2PvZVyXiJsqfYOarlB70VMYL5zZTo0-BQVG_NeAk8VgH0WOEV9jitGR56cnQhcBZRGEoadSLFXw&utm_content=299795638&utm_source=hs_email
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