FDA grants orphan drug designation to AP303 for autosomal dominant PKD
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Key takeaways:
- AP303 is intended for the treatment of autosomal dominant polycystic kidney disease.
- The drug completed its first-in-human study in healthy individuals in Australia.
The FDA has granted orphan drug designation to AP303 for the treatment of autosomal dominant polycystic kidney disease.
“We are excited that AP303 has been granted orphan drug designation,” Gavin Xia, PhD, co-founder, chairman and CEO of Alebund, said in a company press release. “It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with [autosomal dominant polycystic kidney disease] ADPKD. We look forward to advancing AP303 to improve future treatment options for patients in need.”
The orphan drug designation qualifies Alebund Pharmaceuticals for incentives, such as marketing exclusivity, clinical research tax credits and exemption from prescription drug user fees, according to a company press release. AP303 (Alebund Pharmaceuticals) completed its first-in-human study in healthy individuals in Australia and is set for a phase 2 trial in ADPKD.
Reference:
Alebund’s innovative investigational drug AP303 receives FDA orphan drug designation (ODD) for the treatment of autosomal dominant polycystic kidney disease (ADPKD). https://prnmedia.prnewswire.com/news-releases/alebunds-innovative-investigational-drug-ap303-receives-fda-orphan-drug-designation-odd-for-the-treatment-of-autosomal-dominant-polycystic-kidney-disease-adpkd-302101896.html. Published Mar. 29, 2024. Accessed Mar. 28, 2024.
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