Sotatercept Explained

Tradename:Winrevair
Dailymedid:Sotatercept
Routes Of Administration:Subcutaneous
Atc Prefix:None
Legal Us:Rx-only
Legal Us Comment:[1]
Cas Number:1001080-50-7
Drugbank:DB12118
Unii:0QI90BTJ37
Kegg:D09670
Synonyms:ACE-011, MK-7962, sotatercept-csrk
C:3448
H:5264
N:920
O:1058
S:42

Sotatercept, sold under the brand name Winrevair is a medication used for the treatment of pulmonary arterial hypertension. It is an activin signaling inhibitor, based on the extracellular domain of the activin type 2 receptor expressed as a recombinant fusion protein with immunoglobulin Fc domain (ACTRIIA-Fc).[2] It is given by subcutaneous injection.

Sotatercept was approved for medical use in the United States in March 2024.[3] [4]

Medical uses

Sotatercept is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1).

Society and culture

Legal status

In June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Winrevair, intended for the treatment of pulmonary arterial hypertension.[5] [6] The applicant for this medicinal product is Merck Sharp & Dohme B.V.[7]

Economics

Following its approval in 2024, the list price of Winrevair as single-vial and double-vial kit was announced at $14,000 per vial, with an estimated annual cost of $240,000 a year.[8] An independent analysis by the Institute for Clinical and Economic Review determined that Winrevair would be cost-effective for treating PAH if priced between $18,700 and $36,200 annually.[9] ICER's report noted limitations in the available data, including a lack of longer-term studies, uncertainties around the drug's impact on mortality rates, and potential unknown side effects that have not yet surfaced.[10]

Names

Sotatercept is the international nonproprietary name.[11] [12]

Research

It was initially developed to increase bone density[13] but during its early development was found to increase hemoglobin and red blood cell counts,[14] and was subsequently studied for use in anemia associated with multiple conditions including beta thalassemia and multiple myeloma.[15] [16] [17] Development of this drug was superseded by the development of luspatercept (Reblozyl), a modified activin receptor type 2B (ACTRIIB-Fc) based ligand trap with improved properties for anemia.[18] Hypothesizing that this drug might block the effects of activin in promoting pulmonary vascular disease, this molecule was found to inhibit vascular obliteration in multiple models of experimental pulmonary hypertension, providing rationale to reposition sotatercept for PAH in the PULSAR and STELLAR clinical trials for PAH.[19]

Further reading

Notes and References

  1. Web site: Winrevair- sotatercept-csrk kit . DailyMed . 26 March 2024 . 25 April 2024 . 25 April 2024 . https://web.archive.org/web/20240425054612/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21693ee2-cd23-4137-ac67-066bb3a4a9b7 . live .
  2. Doggrell . Sheila A . Is sotatercept, which traps activins and growth differentiation factors, a new dawn in treating pulmonary arterial hypertension (PAH)? . Expert Opinion on Biological Therapy . 23 . 7 . July 2023 . 37269300 . 10.1080/14712598.2023.2221784 . 589–593. 10072/423493 . free .
  3. Web site: Novel Drug Approvals for 2024 . U.S. Food and Drug Administration (FDA) . 29 April 2024 . 30 April 2024 . 30 April 2024 . https://web.archive.org/web/20240430031024/https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 . live .
  4. FDA Approves Merck's Winrevair (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1) . Merck . Business Wire . 27 March 2024 . 27 March 2024 . 27 March 2024 . https://web.archive.org/web/20240327043633/https://www.businesswire.com/news/home/20240326077272/en/FDA-Approves-Merck%E2%80%99s-WINREVAIR%E2%84%A2-sotatercept-csrk-a-First-in-Class-Treatment-for-Adults-with-Pulmonary-Arterial-Hypertension-PAH-WHO*-Group-1 . live .
  5. Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension . European Medicines Agency (EMA) . 28 June 2024 . 29 June 2024.
  6. Web site: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024 . European Medicines Agency . 28 June 2024 . 12 July 2024 . 12 July 2024 . https://web.archive.org/web/20240712152232/https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024 . live .
  7. Web site: Winrevair EPAR . European Medicines Agency . 27 June 2024 . 29 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. Web site: Cohen . Joshua . Winrevair Gains Approval For Pulmonary Arterial Hypertension, But High Price Could Limit Uptake . 6 April 2024 . Forbes . en . 6 April 2024 . https://web.archive.org/web/20240406003325/https://www.forbes.com/sites/joshuacohen/2024/04/02/winrevair-gains-approval-for-pulmonary-arterial-hypertension-but-high-price-could-limit-uptake/ . live .
  9. Web site: Cohen . Joshua . Winrevair Gains Approval For Pulmonary Arterial Hypertension, But High Price Could Limit Uptake . 6 April 2024 . Forbes . en . 6 April 2024 . https://web.archive.org/web/20240406003325/https://www.forbes.com/sites/joshuacohen/2024/04/02/winrevair-gains-approval-for-pulmonary-arterial-hypertension-but-high-price-could-limit-uptake/ . live .
  10. Web site: FirstWord . 6 April 2024 . firstwordpharma.com . en . 6 April 2024 . https://web.archive.org/web/20240406000532/https://firstwordpharma.com/story/5840811 . live .
  11. ((World Health Organization)) . 2010 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 64 . WHO Drug Information . 24 . 3 . 10665/74577 . free . World Health Organization .
  12. ((World Health Organization)) . 2011 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 65 . WHO Drug Information . 25 . 1 . 10665/74623 . free . World Health Organization .
  13. Sherman . Matthew L. . Borgstein . Niels G. . Mook . Louisa . Wilson . Dawn . Yang . Yijun . Chen . Nianhang . Kumar . Ravindra . Kim . Kenneth . Laadem . Abderrahmane . Multiple-dose, safety, pharmacokinetic, and pharmacodynamic study of sotatercept (ActRIIA-IgG1), a novel erythropoietic agent, in healthy postmenopausal women . The Journal of Clinical Pharmacology . November 2013 . 53 . 11 . 1121–1130 . 10.1002/jcph.160 . 23939631 . 0091-2700. free . doi .
  14. Dussiot . Michael . Maciel . Thiago T. . Fricot . Aurelie . Chartier . Celine . Negre . Olivier . Veiga . Joel . Grapton . Damien . Paubelle . Etienne . Payen . Emmanuel . Beuzard . Yves . Leboulch . Philippe . Ribeil . Jean-Antoine . Arlet . Jean-Benoit . Cote . Francine . Courtois . Genevieve . Ginzburg . Yelena Z. . Daniel . Thomas O. . Chopra . Rajesh . Sung . Victoria . Hermine . Oliver . Moura . Ivan C. . An activin receptor IIA ligand trap corrects ineffective erythropoiesis in β-thalassemia . Nature Medicine . Apr 2014 . 20 . 4 . 398–407 . 10.1038/nm.3468 . 24658077. 7730561 .
  15. Abdulkadyrov . Kudrat M. . Salogub . Galina N. . Khuazheva . Nuriet K. . Sherman . Matthew L. . Laadem . Abderrahmane . Barger . Rachel . Knight . Robert . Srinivasan . Shankar . Terpos . Evangelos . Sotatercept in patients with osteolytic lesions of multiple myeloma . British Journal of Haematology . June 2014 . 165 . 6 . 814–823 . 10.1111/bjh.12835. 24650009 . 4312883 . free . doi .
  16. Lan . Zehao . Lv . Zhaohua . Zuo . Wanyun . Xiao . Yichao . From bench to bedside: The promise of sotatercept in hematologic disorders . Biomedicine & Pharmacotherapy . September 2023 . 165 . 115239 . 10.1016/j.biopha.2023.115239. 37516019 . free . doi .
  17. Raje . Noopur . Vallet . Sonia . Sotatercept, a soluble activin receptor type 2A IgG-Fc fusion protein for the treatment of anemia and bone loss . Current Opinion in Molecular Therapeutics . October 2010 . 12 . 5 . 586–597 . 20886391 . 2040-3445 . 4 November 2023 . 4 November 2023 . https://web.archive.org/web/20231104070343/https://europepmc.org/article/med/20886391 . live .
  18. Suragani . Rajasekhar N.V.S. . Cadena . Samuel M. . Cawley . Sharon M. . Sako . Dianne . Mitchell . Dianne . Li . Robert . Davies . Monique V. . Alexander . Mark J. . Devine . Matthew . Loveday . Kenneth S. . Underwood . Kathryn W. . Grinberg . Asya V. . Quisel . John D. . Chopra . Rajesh . Pearsall . R. Scott . Seehra . Jasbir . Kumar . Ravindra . Transforming growth factor-β superfamily ligand trap ACE-536 corrects anemia by promoting late-stage erythropoiesis . Nature Medicine . Apr 2014 . 20 . 4 . 408–414 . 10.1038/nm.3512 . 24658078.
  19. Yung . Lai-Ming . Yang . Peiran . Joshi . Sachindra . Augur . Zachary M. . Kim . Stephanie S.J. . Bocobo . Geoffrey A.l . Dinter . Teresa . Troncone . Luca . Chen . Po-Sheng . McNeil . Megan E. . Southwood . Mark . Poli de Frias . Sergio . Knopf . John . Rosas . Ivan O. . Sako . Dianne . Pearsall . R. Scott . Quisel . John D. . Li . Gang . Kumar . Ravindra . Yu . Paul B. . ACTRIIA-Fc rebalances activin/GDF versus BMP signaling in pulmonary hypertension . Science Translational Medicine . May 2020 . 12 . 543 . eaaz5660 . 10.1126/scitranslmed.aaz5660 . 32404506. 8259900 .

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