The USA's Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sotatercept for pulmonary arterial hypertension (PAH).
US pharma giant Merck & Co’s (NYSE: MRK) fusion protein and activin signaling inhibitor has not yet been approved by the US Food and Drug Administration (FDA), but it has been granted a Priority Review from the regulator and a decision is due on whether to approve it by March 26, 2024.
"Current evidence suggests that sotatercept has fewer side effects and improves short-term outcomes, but we have some uncertainties about long-term efficacy and safety"The company believes it has a first-in-class blockbuster treatment that could bring in up to around $4 billion at peak, but the has not yet announced a US price for the product, if approved.
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