Supplemental FDA approval for Ayvakit to treat indolent systemic mastocytosis
Blueprint Medicines Corporation announced that the FDA has approved Ayvakit (avapritinib) for the treatment of adults with indolent systemic mastocytosis (ISM)
All U.S. patients with ISM now have access to the first and only approved medicine designed to treat their disease.
Systemic mastocytosis (SM) is a rare hematologic disorder that can lead to a range of debilitating symptoms across multiple organ systems and a significant impact on patients' quality of life. ISM represents the vast majority of SM cases, and Ayvakit is now available for adults with ISM at the recommended dose of 25 mg once daily. Ayvakit was designed to potently and selectively inhibit KIT D816V, the primary underlying driver of the disease. Ayvakit has been FDA approved for the treatment of advanced SM since June 2021.
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