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  • Primary biliary cholangitis drug Iqirvo to land in Korea
  • by Eo, Yun-Ho | translator Alice Kang | Feb 24, 2025 05:51am
Ipssen Korea starts the MFDS approval process
Drug receives accelerated approval through a reduction in ALP
The new drug for primary biliary cholangitis Iqirvo may soon be launched in Korea.

According to industry sources, Ipssen Korea is in the process of obtaining marketing authorization from the Ministry of Food and Drug Safety for Iqirvo (elafibranor), a dual peroxisome proliferator-activated receptor (PPAR) alpha/delta (PPAR ¥á, ¥ä) agonist.

The drug was also designated as a rare drug in Korea in June last year. Iqirvo obtained accelerated approval from the US FDA in June last year for the indication of primary biliary cholangitis.

Specifically, the drug is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) who have shown an insufficient response to ursodeoxycholic acid (UDCA)
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