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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

  • 3 min

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Clinical Scorecard: FDA updates PAH label with trial data

At a Glance

CategoryDetail
ConditionPulmonary Arterial Hypertension
Key MechanismsSotatercept improves exercise capacity and functional class, reduces risk of clinical worsening events.
Target PopulationAdults recently diagnosed with pulmonary arterial hypertension (WHO Group 1), functional class II or III.
Care SettingClinical 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

Original Source(s)

FDA updates PAH label with trial data

  • by Kathryn Wighton

  • September 22, 2026

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