Hanmi Pharmaceutical said that the European Medicines Agency (EMA) has granted the orphan drug designation (ODD) to its LAPS Triple Agonist (HM15211) for treating primary sclerosing cholangitis.

The ODD designation comes after the company received the ODD designation for HM1521 for treating primary biliary cholangitis and idiopathic pulmonary fibrosis from the U.S. Food and Drug Administration in March last year and May this year, respectively.

The company stressed that with the recent EMA ODD, HM15211 has received four ODD from the FDA and EMA (three from FDA and one from EMA).

Including HM15211, Hanmi has received ODD for a total of 18 cases for 10 indications in six different pipelines, which is the most among Korean pharmaceutical companies.

Notably, HM15211 has also received a fast-track development designation as a treatment for nonalcoholic steatohepatitis by the FDA in July last year and is receiving close consultation and full support from the FDA at each development stage.

HM15211 induces insulin secretion and anti-inflammatory action by activating the glucagon-Like Peptide-1 (GLP-1) receptor, glucagon receptor, and glucose-dependent insulinotropic polypeptide.

ODD is a status given to certain medications called orphan drugs, which promise to treat, prevent, or diagnose orphan diseases. The designation provides tax and license application fee exemption and grants a monopoly for seven years if it becomes the first drug approved in the field.