Posted by Michael Wonder on 10 Nov 2023
Blueprint Medicines' Ayvakyt (avapritinib) receives positive CHMP opinion as the first and only therapy for indolent systemic mastocytosis
10 November 2023 - Opinion based on the positive PIONEER trial, in which once daily Ayvakyt achieved significant improvements across a broad range of symptoms with a comparable safety profile to placebo.
Blueprint Medicines today announced the CHMP of the EMA has issued a positive opinion recommending the approval of Ayvakyt (avapritinib) for the treatment of adult patients with indolent systemic mastocytosis with moderate to severe symptoms inadequately controlled on symptomatic treatment.
