Sotatercept, sold under the brand name Winrevair is a
medication
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field an ...
used for the treatment of
pulmonary arterial hypertension.
It is an
activin
Activin and inhibin are two closely related protein complexes that have almost directly opposite biological effects. Identified in 1986, activin enhances FSH biosynthesis and secretion, and participates in the regulation of the menstrual ...
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). It is given by
subcutaneous injection
Subcutaneous administration is the insertion of medications beneath the skin either by injection or infusion.
A subcutaneous injection is administered as a bolus into the subcutis, the layer of skin directly below the dermis and epidermis, co ...
.
Sotatercept was approved for medical use in the United States in March 2024.
Medical uses
Sotatercept is
indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1).
Society and culture
Names
Sotatercept is the
international nonproprietary name.
Research
It was initially developed to increase
bone density
Bone density, or bone mineral density, is the amount of bone mineral in bone tissue. The concept is of mass of mineral per volume of bone (relating to density in the physics sense), although clinically it is measured by proxy according to op ...
but during its early development was found to increase hemoglobin and red blood cell counts, and was subsequently studied for use in
anemia
Anemia or anaemia (British English) is a blood disorder in which the blood has a reduced ability to carry oxygen due to a lower than normal number of red blood cells, or a reduction in the amount of hemoglobin. When anemia comes on slowly, ...
associated with multiple conditions including
beta thalassemia
Beta thalassemias (β thalassemias) are a group of inherited blood disorders. They are forms of thalassemia caused by reduced or absent synthesis of the beta chains of hemoglobin that result in variable outcomes ranging from severe anemia to cl ...
and
multiple myeloma
Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Often, no symptoms are noticed initially. As it progresses, bone pain, ane ...
. Development of this drug was superseded by the development of
luspatercept
Luspatercept, sold under the brand name Reblozyl, is a medication used for the treatment of anemia in beta thalassemia and myelodysplastic syndromes.
The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.
...
(Reblozyl), a modified
activin receptor type 2B (ACTRIIB-Fc) based ligand trap with improved properties for anemia. 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.
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. 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. 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.
References
Further reading
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External links
Antihypertensive agents
Peptides
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