BPMC - Blueprint says EMA validated Ayvakyt marketing application for systemic mastocytosis

Blueprint Medicines ([[BPMC]] -1.6%) has announced that the European Medicines Agency has validated its Type II variation marketing authorization application for Ayvakyt (avapritinib) for advanced systemic mastocytosis.With the decision, the company says that the submission process is sufficiently complete for the formal review process to begin.The European Commission has granted the orphan medicinal product designation to Ayvakyt for the treatment of mastocytosis.In December, Blueprint Medicines announced that it submitted a supplemental new drug application for the FDA seeking approval for Ayvakit in adults with advanced systemic mastocytosis.

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Blueprint says EMA validated Ayvakyt marketing application for systemic mastocytosis