Hanmi Pharmaceutical said on Wednesday that its investigational rare disease drug HM15912 to treat short-bowel syndrome has received Fast Track designation from the U.S. Food and Drug Administration.
The South Korean pharmaceutical company is developing the novel once-a-month therapy by using its platform technology LAPSCOVERY.
Short-bowel syndrome is a rare disease that can trigger malnutrition due to malabsorption after a loss of 60 percent or more of functional small intestine due to congenital reasons or after-birth surgical excision. It occurs in about 24.5 out of 100,000 newborns and threatens growth in children and adolescents and makes it difficult for patients and family to live normal lives due to total parenteral nutrition method that takes more than 10 hours every day.
Hanmi Pharmaceutical said the FDA Fast Track designation is another milestone in its efforts to make a difference in the lives of patients with short-bowel syndrome, who have to rely on artificial nutritional supplement for growth and maintenance of life.
Fast Track is a process designed to facilitate the development, and expedite the review, of new therapies intended to treat or prevent serious conditions that have the potential to address an unmet medical need.
One benefit of the fast-track designation is a rolling review, a regulatory tool that the FDA uses to speed up the assessment of a promising medicine. In a rolling review, the FDA reviews data as they become available from ongoing studies before a formal application is submitted.
HM15912 was already designated as Orphan Drug by the FDA and the EMA in 2019. The FDA also granted the drug rare pediatric disease designation last year.
Hanmi Pharmaceutical said it will soon start a global multicenter phase 2 study of the drug in the U.S. and Europe based on phase 1 trial data that demonstrated efficacy in promoting the growth of chorionic cells.
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