Rocket Pharmaceuticals Reaches FDA Alignment in Danon Heart Disease Treatment Trial
12 Setembro 2023 - 5:55PM
Dow Jones News
By Ben Glickman
Rocket Pharmaceuticals said it had reached alignment with the
Food and Drug Administration on its Phase 2 trial of its treatment
for Danon disease.
The Cranbury, N.J.-based pharmaceutical company said its study
would evaluate the use of RP-A501 to treat 12 patients with Danon
disease, a fatal cardiomyopathy with no cure. The Phase 2 trial
will be an open-label study with a biomarker-based co-primary
endpoint assessed after 12 months, the company said.
The trial will support accelerated approval of Rocket's
treatment by the FDA.
The company said it expected to file its Clinical Trial
Application/Investigational Medicinal Product Dossier for RP-A501,
which will allow for studies to take place in the European Union in
the third quarter.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
September 12, 2023 16:40 ET (20:40 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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