[Infostock Daily= Reporter Ryu Ki-Heon] Labs glucagon Analog under development by Hanmi Pharmaceutical has been designated by the US FDA as a rare pediatric disease drug (RPD).
Hanmi Pharmaceutical announced on 26th that the FDA designated Labs glucagon Analog as a rare drug for the treatment of congenital hyperinsulinism in children.
Labs glucagon Analog was approved by the FDA in 2018 as an ODD (designation of rare drugs), and this time it was also designated as an RPD, which is likely to increase the possibility that Hanmi Pharm's innovative new drug candidates will be applied to the FDA's special program for rapid development of medicines.
Congenital hyperinsulinism is a rare disease that causes serious and persistent hyperinsulinism in newborns and children, with one in every 25,000 to 50,000 newborns. About 60% of them are diagnosed within one month of birth, but there are no licensed treatments so far.
It is the world's first once-weekly glucagon candidate material that dramatically improves the short half-life of glucagon promoting glucose synthesis in the body and the lack of solubility and stability in bio-like environment. It is expected that the quality of life of infants and children suffering from chronic hypoglycemia such as congenital hyperinsulinism can be dramatically improved.
Phase I clinical trials are currently underway in the United States as an indication for obesity, and have also been designated as rare medicines for the treatment of congenital hyperinsulinism (2018) and insulin autoimmune syndrome (2020) from European EMA.
Reporter Ryu Ki-Heon okyou93@infostock.co.kr
