| Clinical data | |
|---|---|
| Trade names | Winrevair |
| Other names | ACE-011, MK-7962, sotatercept-csrk |
| License data |
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| Routes of administration | Subcutaneous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C3448H5264N920O1058S42 |
| Molar mass | 77879.94 g·mol−1 |
Sotatercept, sold under the brand name Winrevair is a medication used for the treatment of pulmonary arterial hypertension.[1] It is an activin signaling inhibitor,[1] 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.[1]
Sotatercept was approved for medical use in the United States in March 2024.[1][3][4]
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Transcription
Medical uses
Sotatercept is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1).[1]
Society and culture
Names
Sotatercept is the international nonproprietary name.[5][6]
Research
It was initially developed to increase bone density[7] but during its early development was found to increase hemoglobin and red blood cell counts,[8] and was subsequently studied for use in anemia associated with multiple conditions including beta thalassemia and multiple myeloma.[9][10][11] Development of this drug was superseded by the development of luspatercept (Reblozyl), a modified activin receptor type 2B (ACTRIIB-Fc) based ligand trap with improved properties for anemia.[12] 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.[13]
Society and culture
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.[14] 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.[14] 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.[15]
References
- ^ a b c d e f "Winrevair- sotatercept-csrk kit". DailyMed. 26 March 2024. Archived from the original on 25 April 2024. Retrieved 25 April 2024.
- ^ Doggrell SA (July 2023). "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): 589–593. doi:10.1080/14712598.2023.2221784. PMID 37269300.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
- ^ "FDA Approves Merck's Winrevair (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1)" (Press release). Merck. 27 March 2024. Archived from the original on 27 March 2024. Retrieved 27 March 2024 – via Business Wire.
- ^ World Health Organization (2010). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 64". WHO Drug Information. 24 (3). hdl:10665/74577.
- ^ World Health Organization (2011). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 65". WHO Drug Information. 25 (1). hdl:10665/74623.
- ^ Sherman ML, Borgstein NG, Mook L, Wilson D, Yang Y, Chen N, et al. (November 2013). "Multiple-dose, safety, pharmacokinetic, and pharmacodynamic study of sotatercept (ActRIIA-IgG1), a novel erythropoietic agent, in healthy postmenopausal women". Journal of Clinical Pharmacology. 53 (11): 1121–1130. doi:10.1002/jcph.160. PMID 23939631.
- ^ Dussiot M, Maciel TT, Fricot A, Chartier C, Negre O, Veiga J, et al. (April 2014). "An activin receptor IIA ligand trap corrects ineffective erythropoiesis in β-thalassemia". Nature Medicine. 20 (4): 398–407. doi:10.1038/nm.3468. PMC 7730561. PMID 24658077.
- ^ Abdulkadyrov KM, Salogub GN, Khuazheva NK, Sherman ML, Laadem A, Barger R, et al. (June 2014). "Sotatercept in patients with osteolytic lesions of multiple myeloma". British Journal of Haematology. 165 (6): 814–823. doi:10.1111/bjh.12835. PMC 4312883. PMID 24650009.
- ^ Lan Z, Lv Z, Zuo W, Xiao Y (September 2023). "From bench to bedside: The promise of sotatercept in hematologic disorders". Biomedicine & Pharmacotherapy = Biomedecine & Pharmacotherapie. 165: 115239. doi:10.1016/j.biopha.2023.115239. PMID 37516019.
- ^ Raje N, Vallet S (October 2010). "Sotatercept, a soluble activin receptor type 2A IgG-Fc fusion protein for the treatment of anemia and bone loss". Current Opinion in Molecular Therapeutics. 12 (5): 586–597. PMID 20886391. Archived from the original on 4 November 2023. Retrieved 4 November 2023.
- ^ Suragani RN, Cadena SM, Cawley SM, Sako D, Mitchell D, Li R, et al. (April 2014). "Transforming growth factor-β superfamily ligand trap ACE-536 corrects anemia by promoting late-stage erythropoiesis". Nature Medicine. 20 (4): 408–414. doi:10.1038/nm.3512. PMID 24658078.
- ^ Yung LM, Yang P, Joshi S, Augur ZM, Kim SS, Bocobo GA, et al. (May 2020). "ACTRIIA-Fc rebalances activin/GDF versus BMP signaling in pulmonary hypertension". Science Translational Medicine. 12 (543): eaaz5660. doi:10.1126/scitranslmed.aaz5660. PMC 8259900. PMID 32404506.
- ^ a b Cohen J (April 2024). "Winrevair Gains Approval For Pulmonary Arterial Hypertension, But High Price Could Limit Uptake". Forbes. Archived from the original on 6 April 2024. Retrieved 6 April 2024.
- ^ "FirstWord". firstwordpharma.com. Archived from the original on 6 April 2024. Retrieved 6 April 2024.
Further reading
- "Role of Sotatercept in Management of Pulmonary Arterial Hypertension: The STELLAR Trial". American College of Cardiology.
- Humbert M, McLaughlin V, Gibbs JS, Gomberg-Maitland M, Hoeper MM, Preston IR, et al. (April 2021). "Sotatercept for the Treatment of Pulmonary Arterial Hypertension". The New England Journal of Medicine. 384 (13): 1204–1215. doi:10.1056/NEJMoa2024277. PMID 33789009.
- Humbert M, McLaughlin V, Gibbs JS, Gomberg-Maitland M, Hoeper MM, Preston IR, et al. (January 2023). "Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension". The European Respiratory Journal. 61 (1). doi:10.1183/13993003.01347-2022. PMC 9816418. PMID 36041750.
- Joshi SR, Liu J, Bloom T, Karaca Atabay E, Kuo TH, Lee M, et al. (May 2022). "Sotatercept analog suppresses inflammation to reverse experimental pulmonary arterial hypertension". Scientific Reports. 12 (1): 7803. Bibcode:2022NatSR..12.7803J. doi:10.1038/s41598-022-11435-x. PMC 9098455. PMID 35551212.
- Komrokji R, Garcia-Manero G, Ades L, Prebet T, Steensma DP, Jurcic JG, et al. (February 2018). "Sotatercept with long-term extension for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes: a phase 2, dose-ranging trial". The Lancet. Haematology. 5 (2): e63–e72. doi:10.1016/S2352-3026(18)30002-4. PMID 29331635.
- Yung LM, Yang P, Joshi S, Augur ZM, Kim SS, Bocobo GA, et al. (May 2020). "ACTRIIA-Fc rebalances activin/GDF versus BMP signaling in pulmonary hypertension". Science Translational Medicine. 12 (543): eaaz5660. doi:10.1126/scitranslmed.aaz5660. PMC 8259900. PMID 32404506.
External links
- Clinical trial number NCT04576988 for "A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)" at ClinicalTrials.gov
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This page was last edited on 25 June 2024, at 17:32