ARS Pharmaceuticals to Meet With FDA on Neffy Rejection

By Colin Kellaher

ARS Pharmaceuticals will meet later this month with the U.S. Food and Drug Administration to discuss the agency's rejection of the biopharmaceutical company's proposed epinephrine nasal spray for the treatment of severe allergic reaction.

In a surprise move last month, the FDA declined to approve the spray, which ARS plans to market as "neffy," despite a positive recommendation from one of the agency's advisory committees.

ARS on Friday said the FDA has scheduled a Type A meeting to discuss the contents of the complete response letter the agency issued on the neffy application, including its call for the San Diego company to complete a repeat-dose study prior to approval.

According to FDA guidelines, Type A meetings are aimed at resolving disputes and helping stalled product development programs proceed, with scheduling targeted to occur within 30 days of receipt of a written request.

Following the positive advisory panel in May, the FDA had been expected to approve neffy as the first needle-free epinephrine product for severe allergic reactions.

ARS last month said it had previously reached alignment with the FDA on conducting the repeat-dose study after approval of neffy, and that it planned to dispute the agency's decision.

The company on Friday said it is moving rapidly to conduct the repeat-dose study, adding that the meeting will provide an opportunity to discuss the FDA's position and a pathway forward for neffy.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

October 06, 2023 09:42 ET (13:42 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.