Ahead of FDA decision, Blueprint puts out full data for expanded Ayvakit label
Blueprint Medicines presented the full dataset for its drug Ayvakit at a medical conference over the weekend as it heads towards an FDA decision in May. Blueprint is hoping to expand Ayvakit’s label into a less advanced form of systemic mastocytosis, a rare disease in which too many mast cells, a type of white blood cell, build up in the body.
The drug was approved for the advanced form of the disease in 2021. Blueprint reported topline data for the Phase III PIONEER trial in August, but left a key datapoint in the air.
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