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Winrevair will carry a list price of $14,000 per vial, Oosthuizen said. According to data from the company's trial, most patients will use a single vial every three weeks, which would translate to ...
Sotatercept, sold under the brand name Winrevair is a medication used for the treatment of pulmonary arterial hypertension. [6] It is an activin signaling inhibitor, [ 6 ] based on the extracellular domain of the activin type 2 receptor expressed as a recombinant fusion protein with immunoglobulin Fc domain (ACTRIIA-Fc). [ 9 ]
Winrevair, which costs around $238,000 annually, was the first treatment to secure approval from the U.S. Food and Drug Administration from a class of drugs, which target a type of protein called ...
In March 2024, the FDA approved Winrevair (sotatercept-csrk), for injection, 45mg, 60mg for adults with PAH to increase exercise capacity, improve WHO functional class, and reduce the risk of ...
Romosozumab, sold under the brand name Evenity (/ ɪ ˈ v ɛ n ɪ t i / ih-VENN-ih-tee or with the pin-pen merger, / ɪ ˈ v ɪ n ɪ t i / ih-VINN-ih-tee), is a medication used to treat osteoporosis. [ 7 ] [ 8 ] It has been found to decrease the risk of fractures of the spine .
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
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