Publication of clinical trial results

The information given below and the relevant links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO). They supplement the information published in association with the Swiss marketing authorisation for the medicinal product.

WINREVAIR®

Winrevair® (Sotatercept), powder for solution for injection, 45 mg or 60 mg Sotatercept per vial.

Authorisation number: 69129

Swissmedic authorisation date: 13. September 2024

Pivotal Trials:

PULSAR – NCT03496207: EudraCT Number 2017-004738-27 – Clinical trial results – EU Clinical Trials Register

STELLAR – NCT04576988: EudraCT Number 2020-004142-11 – Clinical trial results – EU Clinical Trials Register

Publications:

Humbert M, et al. Sotatercept for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2021;384(13):1204-1215. DOI: 10.1056/NEJMoa2024277.

Hoeper MM et al. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med;2023;388(16):1478-1490. DOI: 10.1056/NEJMoa2213558.

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