FDA granted accelerated approval for Seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid
Seladelpar (Livdelzi; Gilead Sciences Inc) was granted accelerated approval by the FDA for the treatment of primary biliary cholangitis (PBC) in
FDA questions and seek approval from the FDA to lift the clinical hold. In regulatory approval of seladelpar in PBC and achievement of certain sales for
Seladelpar is beneficial for PBC patients because it reduces bile acid production and helps counteract the liver damage caused by the buildup of bile acids. Seladelpar gained FDA approval on Aug, as the brand name Livdelzi, under the accelerated approval designation.
FDA Approves Seladelpar for Primary Biliary Cholangitis The FDA has granted accelerated approval to seladelpar (Livdelzi, Gilead) in
Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-delta ( ) agonist. Seladelpar is a single enantiomer of the R-configuration. 5 On Aug, seladelpar was granted accelerated approval by the FDA for the treatment of primary biliary cholangitis, 6 which is a
Medication Access Medication Access U.S. Gilead's Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA.
The FDA has granted accelerated approval for Livdelzi (seladelpar) to treat patients with primary biliary cholangitis (PBC) in combination
The therapy has also received an orphan designation from the FDA. If approved, seladelpar will be indicated in combination with UDCA for
Comments
What the hell would the FDA have to do with it? This is a piece of machinery. They would have NO say about it whatsoever.
Good story - would like to see more!