Antares Gets FDA Fast-Track Designation for ATRS-1902 for Adrenal Crisis Rescue
By Michael Dabaie
Antares Pharma Inc. said the U.S. Food and Drug Administration
granted fast-track designation for ATRS-1902 for adrenal crisis
The development program for ATRS-1902 supports a proposed
indication for the treatment of acute adrenal insufficiency, known
as adrenal crisis, in adults and adolescents, the company said.
A drug candidate that receives fast-track designation is
eligible for more-frequent communication with the FDA throughout
the drug-development process and a rolling or priority review of
its marketing application.
"We look forward to working closely with the agency as we
advance our development of ATRS-1902 with an upcoming pivotal
clinical study and an additional human factor study that we
anticipate will support our 505(b)(2) NDA submission by the end of
the year," Chief Medical Officer Peter Richardson said.
Write to Michael Dabaie at firstname.lastname@example.org
(END) Dow Jones Newswires
January 18, 2022 08:17 ET (13:17 GMT)
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