Hanmi Pharm's novel drug receives INN name 'efpegerglucagon' for treating congenital hyperinsulinemia

The International Nonproprietary Name (INN) of LAPS Glucagon analog (code name HM15136), which Hanmi Pharm is developing as an innovative new drug for treating congenital hyperinsulinemia, has been fixed as “efpegerglucagon.”

Hanmi Pharm said Thursday that the World Health Organization has officially registered the INN of HM15136 like that.

The name efpegerglucagon contains the prefix “ef-“ (protein with Hanmi's proprietary platform technology “Labscovery”) and suffix “-glucagon” (glucagon receptor agonist), meaning “long-acting glucagon analog with Labscovery technology.” In the future, the generic name efpegerglucagon should be used for products containing this ingredient.

Hanmi Pharm is developing efpegerglucagon in a once-weekly formulation to treat congenital hyperinsulinemia and is conducting a global phase 2 clinical trial. If commercialized, Hanmi Pharm expects that the new drug will significantly relieve patients in terms of sustained therapeutic effect, safety, and ease of dosing.

Congenital hyperinsulinemia is a rare disease with an incidence of 1 in 25,000 to 50,000 live births, primarily in the neonatal period, which causes severe and persistent hypoglycemia. There is one approved treatment for congenital hyperinsulinemia. Still, treatment response rates are low, leaving patients to rely on off-label medications or surgery to remove the pancreas with all its side effects.

In 2018, the U.S. Food and Drug Administration (FDA), the European Medicine Agency (EMA), and the Korean Ministry of Food and Drug Safety (MFDS) granted efpegerglucagon orphan drug designation for the congenital hyperinsulinemia indication in 2019. 2020, the FDA granted its rare pediatric disease (RPD) designation. The same year, the EMA granted its orphan drug designation for insulin autoimmune syndrome.

The WHO assigns globally accepted and recognized international generic names to certain drug ingredients or substances to prevent the misuse of prescription medicines and to improve information communication and convenience. It periodically announces the newly named international generic names on its website.

Aside from efpegerglucagon, Hanmi Pharm has registered the international generic names of its biologics eflapegrastim (eflapegrastim-rolvedone/Rolontis), efpeglenatide (efpeglenatide-LAPSExd4 analog), efinopegdutide (epinopegdutide-LAPSGLP/GCG agonist), and efocipegtrutide (epocipegtrutide-LAPSTriple agonist) with the WHO.