FDA Accepts REZZAYO sNDA for Priority Review

CorMedix Therapeutics announced that the U.S. Food and Drug Administration has accepted a supplemental New Drug Application for REZZAYO, according to Quiverquant. The application concerns REZZAYO, or rezafungin for injection, for prophylaxis of invasive fungal disease.

Quiverquant reported that the FDA also granted priority review to the supplemental application. The publisher said the sNDA was submitted by Mundipharma, identified as CorMedix’s partner.

Supplemental application enters FDA review

The reported FDA acceptance brings the proposed prophylaxis use of REZZAYO into the agency’s review process. According to Quiverquant, the submission is intended to support prevention of invasive fungal disease.

Quiverquant’s summary states that the application is backed by positive results. The supplied report does not provide further detail on those results, and no final FDA decision has been reported.

The regulatory update concerns a supplemental application rather than a newly submitted application. Quiverquant identifies REZZAYO as rezafungin for injection and identifies invasive fungal disease prophylaxis as the proposed use under review.

Priority review and target action date

Quiverquant reported a target FDA action date in Q1 2027 for the REZZAYO sNDA. The publisher described the review as priority review.

FDA acceptance and priority review are regulatory steps reported by Quiverquant. They do not represent a final decision on the proposed prophylaxis indication.

For pharmaceutical and biotech sales professionals, the development is a regulatory milestone involving CorMedix, Mundipharma, REZZAYO, and the proposed prevention of invasive fungal disease. The next reported timing marker is the Q1 2027 target action date.

What the reported update covers

• FDA acceptance of the REZZAYO supplemental New Drug Application.
• Priority review, as reported by Quiverquant.
• Prophylaxis of invasive fungal disease as the proposed use.
• A target FDA action date in Q1 2027.

Quiverquant attributes the announcement to CorMedix Therapeutics and reports that Mundipharma submitted the application. The FDA review remains pending based on the supplied report.