BioPharma Dive August 15, 2024
Kristin Jensen

Livdelzi, now approved for primary biliary cholangitis, will compete for market share with Ipsen’s Iqirvo and Alfasigma’s Ocaliva.

Dive Brief:

  • Gilead Sciences has won Food and Drug Administration approval to sell Livdelzi, a new medicine for a rare liver disease known as primary biliary cholangitis.
  • The FDA clearance covers patients who can’t tolerate a commonly used treatment called ursodeoxycholic acid or those whose disease doesn’t respond well enough to the older medicine alone. For the latter group of patients, the regulatory clearance specifies combination use of Livdelzi and ursodeoxycholic acid, Gilead said Wednesday.
  • Livdelzi’s approval comes just a few months after Gilead spent $4.3 billion to buy CymaBay Therapeutics, the company that developed the drug, then known as seladelpar....

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Topics: Biotechnology, FDA, Govt Agencies, Mergers & Acquisitions / JV, Pharma, Pharma / Biotech, Trends
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