FDA grants orphan drug designation for Xorlo to treat autosomal dominant PKD
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Key takeaways:
- Xorlo received orphan drug designation from the FDA.
- Xorlo is designed to treat autosomal dominant PKD.
The FDA granted orphan drug designation for Xorlo, a drug from Xortx Therapeutics Inc. intended to treat autosomal dominant polycystic kidney disease, according to the press release.
“Orphan drug designation represents a major milestone for the company in pursuit of marketing approval for Xorlo, our proprietary formulation of oxypurinol, and the XRx-008 program for [autosomal dominant PKD] ADPKD,” Allen Davidoff, PhD, founder and CEO of Xortx Therapeutics Inc., said in the release.
Oxypurinol is a xanthine oxidase inhibitor (XOI) with the ability to inhibit the production of uric acid in the circulation of kidney and cardiovascular tissue. Xorlo is designed to provide an increased absorption of oxypurinol, according to the release, and therefore may be a stronger XOI to slow kidney function decline during ADPKD progression.
In recently presented results in animal models of PKD, Xortx presented positive results of Xorlo for attenuating kidney expansion.
“This designation was a significant and critical milestone for all of the staff and management at the company,” Davidoff said in the release. “Further our potential partners indicated that it was a critical requirement underpinning their ongoing consideration of the Xorlo program. We look forward to our upcoming meeting with the FDA on May 1, 2023, to discuss our planned phase 3 clinical program for Xorlo.”
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