FDA updates PAH label with trial data
In adults diagnosed with pulmonary arterial hypertension within the previous year, adding sotatercept to background therapy reduced the risk of clinical worsening events by 76% compared with placebo.
By
Kathryn Wighton
September 22, 2026
Clinical Scorecard: FDA updates PAH label with trial data
At a Glance
Category Detail
Condition Pulmonary Arterial Hypertension Key Mechanisms Sotatercept improves exercise capacity and functional class, reduces risk of clinical worsening events. Target Population Adults recently diagnosed with pulmonary arterial hypertension (WHO Group 1), functional class II or III. Care Setting Clinical trial setting, phase 3 HYPERION trial.
Key Highlights
Sotatercept reduced risk of clinical worsening events by 76% compared to placebo. Primary efficacy endpoint was time to first confirmed clinical worsening event. Common adverse reactions included epistaxis, telangiectasia, and increased hemoglobin. Guideline-Based Recommendations
Diagnosis
Diagnosis of pulmonary arterial hypertension within 12 months of screening. Management
Sotatercept is approved for improving exercise capacity and reducing clinical worsening. Monitoring & Follow-up
Monitor hemoglobin and platelet levels before each of the first 5 doses and periodically thereafter. Risks
Contraindicated in patients with serious hypersensitivity to sotatercept-csrk or its excipients. Patient & Prescribing Data
320 adults with WHO functional class II or III pulmonary arterial hypertension.
72% received double background therapy, 28% triple therapy, and 17% prostacyclin infusion therapy.
Clinical Best Practices
Consider the risk of epistaxis when prescribing sotatercept. Discontinue treatment if serious adverse reactions occur. Related Resources & Content
