The U.S. FDA has designated LAPSTriple Agonist (HM15211), which Hanmi Pharm is developing as a new innovative drug, as an orphan drug for treating PBC (Primary biliary cholangitis).
This is the second such case since the FDA designated LAPSTriple Agonist as an orphan drug for the treatment of primordial sclerotic bileitis on March 5. Accordingly, Hanmi Pharm has secured the potential for development of treatment for not only non-alcoholic fatty hepatitis but also various autoimmune liver diseases.
The FDA’s Orphan Drug Designation is a system that helps develop and permit treatments for rare and incurable diseases or life-threatening diseases.
Various benefits will be granted, including tax breaks, exemption of the cost of applying for permits, and exclusive rights for seven years to approve the marketing license for the first time among products of the same class.
Under the designation of the orphan drug, there have been a total of 10 cases in which Hanmi Pharm has received rare drug designation from the U.S. FDA and European EMA so far.
"We are doing a lot of research not only in metabolic and anti-cancer diseases, but also in rare incurable diseases, so we expect good results to continue," said Kwon Se-chang, CEO of Hanmi Pharm.