|Hanmi Pharmaceutical’s HM15136 (LAPS Glucagon Analog) has been designated as a rare pediatric disease drug by the U.S. FDA. (Hanmi Pharmaceutical)|
The U.S. Food and Drug Administration designated Hanmi Pharmaceutical's HM15136 (LAPS Glucagon Analog) as a therapy for rare pediatric disease (RPD) of congenital hyperinsulinism on Wednesday.
LAPS Glucagon Analog is the world’s first single-dose candidate that improves the short half-life of glucagon that promotes glucose synthesis in the body and the poor solubility and stability in a simulated body environment.
RPD designation is a program run by the FDA to encourage the development of new drug candidates to prevent or treat rare diseases in children. FDA awards priority review voucher (PRV) to firms that received approval for a drug or biologic for an RPD.
PRV means that the FDA would aim to render a decision in six months, which is useful to win approval as the administration usually tries to complete a standard review in 10 months. The voucher may be traded or transferred.
Congenital hyperinsulinism is a rare disease that causes severe and persistent hypoglycemia in infants and children.
There is no approved drug for the disease and only off-label use or insufficient treatment is available so far. Therefore, the risk of brain damage due to severely low blood sugar level is high.
“Twelve of our developing new drug pipelines have received designations from the FDA or the European Medicines Agency,” Hanmi Pharmaceutical CEO Kwon Se-chang said.