CymaBay seeks approval for PBC management including pruritus in adults without cirrhosis or with compensated cirrhosis who are inadequate responders or intolerant to ursodeoxycholic acid
CymaBay seeks FDA approval for Seladelpar. (Credit: danilo.alvesd on Unsplash)
CymaBay Therapeutics has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Seladelpar to treat primary biliary cholangitis (PBC).
Seladelpar is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist.
CymaBay seeks approval for PBC management, including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid (UDCA).
The biopharmaceutical company has also requested a Priority Review of the NDA that, if accepted, would mean the FDA will aim to finish its evaluation within six months of receiving the application.
Seladex has been granted Breakthrough Therapy Designation by the FDA as the only potent, selective, oral active delpar, or PPARδ agonist.
The drug candidate’s Phase 3 trial results have shown a statistically significant improvement in markers of cholestasis related to risk of progression and primary biliary cholangitis-related pruritus.
The NDA application is supported by the data assessing the safety and effectiveness of Seladelpar in over 500 PBC participants across the placebo-controlled Phase 3 RESPONSE and ENHANCE studies, the long-term open-label ASSURE study, and previous Phase 2 studies.
CymaBay Therapeutics chief regulatory and compliance officer Klara Dickinson said: “People living with PBC need new treatment options to reduce the risk of disease progression and the daily impact of their disease from debilitating symptoms like pruritus.
“Today’s announcement of our submission of the NDA for Seladelpar is an important milestone in our ongoing work to bring forward new innovative therapies with the potential to help people living with PBC.
“We would like to extend our thanks to the participants, their families, and all the investigators who have taken part in studies of Seladelpar to date, which together have enabled the clinical development and submission of Seladelpar for FDA approval.”
In the first half of 2024, CymaBay plans to submit applications for marketing authorisation to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.