BridgeBio Seeks FDA Approval of Acoramidis in Transthyretin Amyloid Cardiomyopathy
05 12월 2023 - 10:52PM
Dow Jones News
By Colin Kellaher
BridgeBio Pharma has filed for U.S. Food and Drug Administration
approval of its acoramidis drug candidate for the heart disease
transthyretin amyloid cardiomyopathy, or ATTR-CM.
The Palo Alto, Calif., biopharmaceutical company on Tuesday said
the filing is based on positive results from a Phase 3 study,
including an 81% absolute survival rate.
Pfizer's tafamidis, which the drugmaker sells as its
Vyndaqel/Vyndamax family, is currently the only approved U.S.
treatment for ATTR-CM, a disease in which abnormal protein builds
up on the heart and can lead to heart failure.
BridgeBio said the FDA has a 60-day filing review period to
determine whether the application is complete and accepted for
review, adding that it plans to submit additional applications to
global health authorities in 2024.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 05, 2023 08:37 ET (13:37 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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