Zosano Pharma Corporation ZSANQ

ZSAN REQUESTED MEETING + FDA TO RESUBMIT APPS FOR QRYPTA &

[Humanist]

Zosano Pharma Requests Type A Meeting with the FDA to Review Resubmission Plans for Qtrypta™ New Drug Application
 
 
Zosano Pharma Corporation

Mon, January 4, 2021, 4:05 PM EST·3 min read
FREMONT, Calif., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that on December 30, 2020 the company requested a Type A meeting with the U.S. Food and Drug Administration (FDA).

The purpose of the Type A meeting is to receive FDA input on the requirements for the resubmission of the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA) following the Complete Response Letter (CRL) received on October 20, 2020. Qtrypta is Zosano’s proprietary investigational formulation of zolmitriptan delivered utilizing its proprietary transdermal microneedle system developed for the acute treatment of migraine. The NDA included data on a total of 774 subjects across 5 trials who were administered or dosed with Qtrypta.

“We have been working diligently to prepare the meeting package required at the time a Type A meeting request is submitted to FDA. We are sharply focused on the resubmission of the NDA for Qtrypta and have been preparing strategies to address the comments received,” said Steven Lo, President and CEO of Zosano. “We look forward to discussing our proposed plans with the FDA, and we expect that the Type A meeting will provide valuable insight into the agency’s expectations for a resubmission package.”

The FDA typically responds to a sponsor’s request for a Type A meeting, if granted, with a meeting scheduled within 30 days from the receipt of the request.

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