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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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  • 1

    The FDA updated the sotatercept-csrk (Winrevair) label with data from the phase 3 HYPERION trial for pulmonary arterial hypertension.

  • 2

    Sotatercept is approved to improve exercise capacity and reduce clinical worsening events in adults with pulmonary arterial hypertension.

  • 3

    The HYPERION trial involved 320 adults with World Health Organization functional class II or III pulmonary arterial hypertension.

  • 4

    Sotatercept reduced the risk of clinical worsening events by 76% compared to placebo, with 11% of patients experiencing worsening.

  • 5

    Common adverse reactions included epistaxis and telangiectasia, with treatment discontinuation in 3% of patients receiving sotatercept.

Original Source(s)

FDA updates PAH label with trial data

  • by Kathryn Wighton

  • September 22, 2026

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