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FDA Grants Priority Review to Sotatercept for Pulmonary Arterial Hypertension

Granted a PDUFA date in March 2024, if approved, sotatercept would be a first-in-class medication to address the rare and progressive disease.

Mariusm hoeperJoerg koglinHannover medical schoolEuropean medicines agencyDrug administrationMerck research laboratoriesAmerican college of cardiologyPrescription drug user fee actMerck researchAnnual scientific sessionsBreakthrough therapy designationOrphan drugPriority medicinesEuropean medicines

Sotatercept Tied to Disease Modification in PAH

Data show sotatercept may deliver significant clinical benefits and could reshape the trajectory of this challenging disease.

France generalTufts medical centerUnited statesOlivier sitbonMariusm hoeperAcceleron pharmaIoanar prestonVallerie mclaughlinAltavant sciencesEuropean respiratory societyUniversity of michiganFrench referral centerAcceleron pharmaceuticalsInternational congressSteering committee of acceleronRespiratory medicine

Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH)

Interim results from SOTERIA open-label extension study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy improvements maintained after one year of therapy

United statesAnn arborMariusm hoeperEliav barrMaheshj patelRogier klokVallerie mclaughlinIoanar prestonIoana prestonDominik lautschPopulation health model predicting the longPulmonary hypertension programEuropean respiratory societyMerck research laboratoriesDrug administrationDivision of cardiovascular medicine

Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH)

Exploratory post-hoc analysis of STELLAR shows potential of sotatercept to improve cardiovascular function Interim results from SOTERIA open-label extension study represent longest safety and.

United statesMariusm hoeperMaheshj patelIoana prestonIoanar prestonRogier klokVallerie mclaughlinEliav barrDominik lautschPopulation healthEuropean respiratory societyExchange commissionBristol myers squibbMerck co incTufts university school of medicineDrug administration

ACC: Sotatercept Boosts Exercise Capacity With Pulmonary Arterial Hypertension

ACC: Sotatercept Boosts Exercise Capacity With Pulmonary Arterial Hypertension
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Mariusm hoeperAcceleron pharmaAmerican college of cardiologyHannover medical schoolWorld health organizationHealthday newsNew england journalAmerican collegePulmonary arterial hypertension symptomsImpact physical impactsCardiopulmonary symptoms