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  • Elafibranor receives orphan drug designation in Korea
  • by Eo, Yun-Ho | translator Kang, Shin-Kook | Jun 17, 2024 05:46am
Ipsen's new drug for biliary cholangitis 
The drug received the U.S. FDA¡¯s accelerated approval recently
Presented additional analysis results on its Phase III trial at EASL Congress 2024.
The biliary cholangitis drug 'elafibranor' has been designated as an orphan drug in Korea.

The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an announcement.

Elafibranor, a dual peroxisome-activated peroxisome receptor alpha/delta (PPAR ¥á,¥ä) agonist that is being developed by Ipsen, received accelerated approval from the U.S. FDA for the primary biliary cholangitis indication on Nov. 10.

More specifically, the drug is indicated for the treatment of adult patients with primary biliary cholangitis who have had an inadequate response to ursodeoxycholic acid (UDCA) or who cannot tolerate UDCA monotherapy due to tolerability issues.

The FDA¡¯s accelerated approval is base
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