Hanmi Pharmaceutical's Triple-Action Biologic Designated as Orphan Drug for 'Idiopathic Pulmonary Fibrosis' by EMA
Number of Orphan Drug Designations Rises to 20, Including FDA Approvals
Six Designations for "LAPS Triple Agonist" Alone
[Asia Economy, reporter Lee Gwanju] Hanmi Pharmaceutical announced on June 9 that its triple-action biologic drug, "LAPS Triple Agonist (HM15211)," has received an additional orphan drug designation from the European Medicines Agency (EMA) for the treatment of idiopathic pulmonary fibrosis (IPF).
With this latest designation, Hanmi Pharmaceutical now holds a total of 20 orphan drug designations across 10 indications in 6 pipelines (9 from the US FDA, 8 from the EMA, and 3 from the Korean Ministry of Food and Drug Safety).
Among these, LAPS Triple Agonist has received a total of 6 orphan drug designations from the FDA and EMA for the indications of primary biliary cholangitis, primary sclerosing cholangitis, and idiopathic pulmonary fibrosis.
LAPS Triple Agonist is a triple-action agent that simultaneously activates the GLP-1 receptor, glucagon receptor, and GIP receptor. It targets "glucagon" to inhibit fibrosis, "GLP-1" to promote insulin secretion and suppress appetite, and "GIP" to enhance insulin secretion and provide anti-inflammatory effects.
The orphan drug designation system is designed to support the development and approval of treatments for rare, intractable, or life-threatening diseases. In Europe, benefits include reduced application fees and, in the case of first approval among products in the same class, a 10-year market exclusivity period.
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Kwon Sechang, CEO of Hanmi Pharmaceutical, stated, "The triple-action biologic LAPS Triple Agonist continues to demonstrate significant potential not only for its primary indication of nonalcoholic steatohepatitis (NASH) but also for various rare diseases that cause fibrosis. We will do our utmost to advance development and commercialization to improve the quality of life for patients suffering from rare diseases."
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