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 rescue.

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 [e-mail]

(END) Dow Jones Newswires

01-18-22 0817ET