Sotatercept-csrk

(Winrevair®)

Winrevair®

Drug updated on 9/4/2024

Dosage FormInjection (45 mg, 60 mg lyophilized cake or powder in a single-dose vial)
Drug ClassActivin signaling inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events.

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Summary
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  • Winrevair (sotatercept-csrk) is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.
  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Sotatercept vs. Placebo: Sotatercept demonstrated greater improvement in pulmonary vascular resistance and WHO functional class in PAH patients compared to placebo.
  • PAH Patients with Anemia: Sotatercept showed an impact on hemoglobin levels, with potential implications for about 33% of PAH patients who experience anemia, necessitating further investigation into the benefits and risks for this subgroup.
  • The occurrence of adverse events was similar between the Sotatercept and placebo groups; however, an increase in hemoglobin levels was observed more frequently in the Sotatercept group, which may be relevant for PAH patients with anemia or polycythemia.
  • There is no safety information available in the reviewed studies for Fasudil, Anastrozole, Tacrolimus, or Metformin.
  • Population Types and Subgroup Considerations: Sotatercept’s erythropoietic properties are particularly relevant for PAH patients with anemia, who constitute approximately 33% of this population. There is also a higher prevalence of PAH among older individuals, suggesting potential implications of Sotatercept's observed benefits in improving pulmonary vascular resistance and WHO functional class for these subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Winrevair (sotatercept-csrk) Prescribing Information2024Merck & Co., Rahway, New Jersey

Systematic Reviews / Meta-Analyses