Hanmi Pharm’s New Drug for Liver Disease Receives Orphan Drug Designation in Europe


A liver disease drug candidate in development at Hanmi Pharmaceutical has been designated as an orphan drug by the European Medicines Agency (EMA).

Hanmi Pharmaceutical announced its new bio drug LAPSTriple Agonist HM15211 has been granted an orphan drug designation by the EMA for the treatment of primary sclerosing cholangitis (PSC).

According to the company, HM15211 was also designated as an orphan drug designation by the US Food and Drug Administration (FDA) in March and May for the treatment of PSC, primary biliary cholangitis (PBC), and idiopathic pulmonary fibrosis (IPF).

LAPSTriple Agonist is a triple agonist that simultaneously activates the GLP-1 receptors, glucagon receptors, and the GIP receptors. The company expects that it will dramatically improve the quality of life for the patients by mitigating the excessive build-up of bile acids in the liver and inhibiting liver inflammation and fibrosis, boosted by its triple action.

Hanmi Pharm reported that the “’Orphan Drug Designation (ODD)’ program of the FDA and EMA are designed to encourage the development and approval of treatments for rare and fatal diseases. In the case of Europe, ODD comes with diverse benefits such as a waiver of application fees, 10 years of exclusive rights in the case of a first-in-class drug approved for marketing.”

With the additional orphan drug designation of HM15211, Hanmi Pharm has gained a total of 18 orphan drug designations with 9 from the FDA, 6 from the EMA, and 3 from the Ministry of Food and Drug Safety (MFDS) of Korea for 6 pipelines based on 10 indications.

Source: News 1