À̹ÌÁö È®´ë A new biologic treatment for short-bowel syndrome developed by South Korea¡¯s Hanmi Pharmaceutical Co. is granted with rare pediatric disease designation by the U.S. Food and Drug Administration (FDA) less than a year after it won orphan status in the U.S.
According to Hanmi Pharmaceutical on Tuesday, LAPS GLP-2 Analog (Code: HM15912) under investigation has been additionally named as rare pediatric disease medicine, bringing up the total number of the company¡¯s innovative novel drug candidates registered as orphan and rare pediatric disease drugs in the United States and Europe to more than 30.
The latest designation of the new biologic candidate came less than a year after it won orphan drug status from the U.S. FDA. The company¡¯s another novel drug candidate for the treatment of congenital hyperinsulinosis treatment also won rare pediatric disease status from the U.S. FDA on June 24.
Like the orphan drug designation program, a drug granted with FDA¡¯s rare pediatric disease status will be given various benefits. The status is granted to drugs for the treatment of serious or life-threatening diseases affecting fewer than 200,000 people in the U.S., primarily those 18 years or younger. The developer of a drug granted with the status can receive a priority review voucher applicable to a subsequent marketing application upon marketing approval.
Short-bowel syndrome is a rare disease that can trigger malnutrition due to malabsorption after loss of 60 percent or more of functional small intestine due to congenital reasons or after-birth surgical excision. Artificial nutritional supplement such as through total parenteral nutrition method is necessary for growth and maintenance of life.
Short-bowel syndrome in infants, in particular, occurs in about 24.5 out of 100,000 newborns. The syndrome can threaten 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 is aiming to develop a new drug for short-bowel syndrome that requires only once monthly administration using its platform technology LAPSCOVERY.
The phase 1 clinical trial of the drug candidate to treat indication with short-bowel syndrome is currently underway in Korea. It plans to launch phase 2 trial in the U.S. and Europe in the second half of this year.
Shares of Hanmi Pharmaceutical finished 0.61 percent lower at 243,500 won ($203) on Tuesday.
By Seo Jin-woo and Lee Eun-joo
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