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Blueprint Medicines: AYVAKIT PIONEER Trial Meets Primary, Key Secondary Goals In SM Patients

(RTTNews) - Blueprint Medicines Corp. (BPMC) announced Wednesday positive top-line results from PIONEER trial of AYVAKIT (avapritinib) in patients with non-advanced systemic mastocytosis or SM. The company plans to submit supplemental new drug application or sNDA to the U.S. Food and Drug Administration in the fourth quarter of 2022.

In pre-market activity on Nasdaq, the company shares were losing around 14 percent to trade at $58.99.

The data from the registrational Part 2 of the PIONEER clinical trial of AYVAKIT (avapritinib) in patients with non-advanced SM demonstrated clinically meaningful and highly significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden.

Based on these top-line data, Blueprint Medicines plans to submit a sNDA to the FDA for AYVAKIT, and a subsequent submission of a type II variation marketing authorization application to the European Medicines Agency or EMA in 2023.

In addition, Blueprint Medicines plans to present detailed data from the PIONEER trial at an upcoming medical meeting.
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