ARS Pharmaceuticals to Meet With FDA on Neffy Rejection
October 06 2023 - 8:57AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 06, 2023 09:42 ET (13:42 GMT)
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