Blueprint Medicines Gets FDA Priority Review for Ayvakit in Indolent Systemic Mastocytosis
2023年1月23日 - 10:51PM
Dow Jones News
By Colin Kellaher
Blueprint Medicines Corp. on Monday said the U.S. Food and Drug
Administration granted priority review to its application seeking
expanded approval of Ayvakit for adults with indolent systemic
mastocytosis, a rare blood disorder.
The Cambridge, Mass., company said the application is based on
its registrational "Pioneer" study, in which Ayvakit achieved its
primary and all key secondary endpoints, with highly meaningful
reductions in patient-reported symptoms and all measures of mast
cell burden studied.
The FDA granted priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review period.
Blueprint said the agency has set a target action date of May 22
for its application.
The FDA in 2021 approved Ayvakit for adults with advanced
systemic mastocytosis, including patients with aggressive systemic
mastocytosis, systemic mastocytosis with an associated
hematological neoplasm, and mast cell leukemia.
Blueprint reported net product revenue of $28.6 million from
sales of the drug in the third quarter of 2022.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 23, 2023 08:36 ET (13:36 GMT)
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