EMA Supports Approval of Gilead’s Liver Disease Drug from $4.3B CymaBay Acquisition
Gilead Acquisition:
Gilead Sciences acquired CymaBay Therapeutics in a $4.3 billion deal to gain access to seladelpar, an experimental drug for primary biliary cholangitis (PBC), a chronic liver condition1.
EMA Approval:
The European Medicines Agency (EMA) has backed the approval of Gilead's liver drug from the $4.3 billion deal, indicating a positive step towards its market availability4.
Clinical Data:
Gilead has presented data showing that seladelpar improves outcomes in PBC patients over two years, including sustained reductions in liver damage biomarkers and itching relief3.
Market Potential:
Analysts predict peak annual sales of $500 million to $2 billion for seladelpar, positioning it as a significant competitor in the PBC treatment market1.
Regulatory Timeline:
The FDA is scheduled to make a decision on seladelpar's approval by mid-August, with Gilead anticipating a second-line label for ALP normalization3.
Sources:
1. https://www.biopharmadive.com/news/gilead-cymabay-deal-acquire-seladelpar-liver-pbc/707218/
3. https://www.fiercebiotech.com/biotech/gilead-approval-sight-shows-43b-liver-disease-drug-improves-outcomes-out-2-years
4. https://www.newsnow.com/ro/?searchheadlines=1&search=%22EMA%22