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Hanmi's Short Bowel Syndrome Drug Gets FDA Fast-Track Status

Hanmi Pharmaceutical said Wednesday that the U.S. Food and Drug Administration has granted fast-track designation to its short-bowel syndrome therapy, LAPS GLP-2 Analog (HM15912).


Hanmi Pharmaceutical said the U.S. Food and Drug Administration has granted fast-track status to its short-bowel syndrome drug LAPS GLP-2 Analog (HM15912).


LAPS GLP-2 Analog is a new biopharmaceutical being developed for short-bowel syndrome with the company's platform technology, known as Labscovery. Short-bowel syndrome is a rare disorder where patients are born with or losing more than 60 percent of the small intestine due to surgical resection, causing malnutrition induced by lack of absorption ability.


The disorder occurs in about 24.5 out of 100,000 newborns and severely affects children and adolescents' growth, with a survival rate below 50 percent. Patients need nutritional supplementation, such as total parenteral nutrition, for their growth and survival.


The FDA gives fast-track status to speed up developing important new drugs that could treat severe illnesses and satisfy the unmet patients' needs.


The fast-track designation allows a company to apply for a license based on completed sections rather than waiting until FDA ends the review, cutting short FDA's priority review period from 10 months to six months.


LAPS GLP-2 Analog was designated as an orphan drug by the FDA and European Medicines Agency (EMA) in 2019 and received rare pediatric drug (RPD) status from the FDA last year.


The company plans to launch multinational phase 2 clinical trials in the U.S. and Europe, based on persistent effect and excellent growth promotion confirmed in the phase 1 study conducted in Korea.


"We are stepping up efforts for patients suffering from rare diseases to fulfill the company's policy of respecting humanity and creating value," Hanmi Pharmaceutical CEO Kwon Se-chang said. "Hanmi would develop innovative treatments that can dramatically improve patients' quality of life suffering from diseases."