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- FDA approves Botanix’s strategy for Sofdra drug application resubmission
- The resubmission process is tipped to take six months
- Botanix last traded at 16.5 cents at 9:45am AEDT
Botanix Pharmaceuticals (BOT) has received positive feedback from the US FDA regarding its resubmission plan for its product Sofpironium Bromide gel (“Sofdra”).
Sofdra is, in short, a drug that reduces sweating. Botanix is seeking to treat the condition axillary hyperhidrosis – in layman’s terms, chronic and excessive sweating.
The resubmission nod from the US regulator follows an “end of review” meeting request lodged back in September.
All papers in order
In turn, the FDA has affirmed that Botanix has everything it needs in order to file a resubmission for the application.
Some users on HotCopper voiced grievances with management on Monday morning for its first FDA application not passing muster.
The company is set to submit the final components required for FDA approval in early Q1CY24, with an anticipated 6-month review period targeting approval around the start of H2.
Resubmission particulars
The materials for resubmission include revised patient instructions for use (“IFU”), a new human factors validation study protocol and report, an updated use-related risk analysis, and updated draft prescribing information.
Additionally, Botanix will submit the proposed proprietary name Sofdra.
The company will also present fresh safety data to the FDA encompassing a report from Japan, and, “any new safety findings reported in the scientific literature.”
“Rapid turnaround” hopes
“We are thankful to the Division for confirming the approach and materials proposed to be included in the resubmission of the NDA for Sofdra, which we are on track to file in early 1Q CY2024,” Botanix CEO Dr. Howie McKibbon said.
“The team will be working over the holiday break to ensure we complete the human factors study and assemble the materials for resubmission to allow a rapid turnaround and filing with FDA for Sofdra approval.”
Investors can look forward to further developments as Botanix Pharmaceuticals progresses towards the regulatory milestones for Sofdra.
Botanix last traded at 16.5 cents at 9:45am AEDT.
