The FDA granted Hanmi Pharmaceutical’s drug HM15912 rare pediatric disease designation for the treatment of short-bowel syndrome, reported Pulse.
The therapy received an orphan drug designation from the FDA less than a year ago.
The drug is currently being tested in a Phase I trial in Korea. Hanmi plans to launch a Phase II trial in the US and Europe in the second half of this year.
The company intends to develop a new drug for short-bowel syndrome that only needs to be administered once a month using its platform technology LAPSCOVERY.