HC017AA is the first Orphan Drug Designation (ODD) Granted for Alopecia Areata in the pediatric patients by the FDA
HCell Inc., a privately held biotechnology company based in Austin, Texas, focusing on Alopecia Areata in the Pediatric Population, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to HC017AA for the treatment of pediatric patients with alopecia areata, a devastating hair loss disease.
The FDA grants Orphan Drug Designation status to drugs and biologics that treat rare diseases, which is defined as those affecting fewer than 200,000 people, in the U.S. The FDA Office of Orphan Products Development evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to advance scientific development of such promising medical products.
HCell Inc. is also working on initiating regulatory steps for HC0100, which comprises proprietary composition and procedure for the treatment of Androgenic Alopecia conditions in both men and women. Further, HCell Inc. is planning pre-clinical development with the intent to launch a human clinical study in the U.S.
Due to the proprietary and highly trade-secreted nature of HCell Treatment, we are protecting our intellectual assets with solid patent protection. HCell Treatment has been successfully patented—both patents, methodology and composition for hair growth, have already been granted in the United States and South Korea. Additionally, we have patents pending in Japan and with the Patent Cooperative Treaty covering 140 countries.