If approved, the company plans to launch saroglitazar in the US in Q4 of FY27.
“The acceptance of our NDA with priority review highlights the significant unmet need that exists for patients with PBC and represents an important step in the path to making saroglitazar available in the US,” said Managing Director of Zydus Lifesciences, Sharvil Patel.
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“We look forward to collaborating with the US FDA during the NDA Priority Review process and will, in parallel, continue to build our medical affairs and commercialisation capabilities towards a potential US launch in the fourth quarter of FY27.”
The proposed indication is for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA, the company said in a statement.
The US FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27.Priority review directs US FDA attention and resources to applications for drugs that, if approved, may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
The NDA is supported by the EPICS-III trial Phase 3 results that evaluated saroglitazar in adult patients with PBC who had an inadequate response to or intolerance of UDCA.
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The trial results demonstrated significant biochemical response and data will be presented as a late-breaking session at the European Association for the Study of the Liver (EASL) Congress in Barcelona, Spain on Saturday.
In the EPICS-III trial Phase 3 results, saroglitazar met the primary endpoint of biochemical response, with 56.7% of patients treated with saroglitazar achieving biochemical response versus 9.8% of patients receiving placebo, a treatment difference of 48%.
Saroglitazar demonstrated a treatment difference of 40.1% in mean alkaline phosphatase (ALP) levels, reducing ALP by 33.5% versus a 6.5% increase among patients receiving placebo.
Saroglitazar was generally well-tolerated in the EPICS-III trial. Most adverse events were mild to moderate in nature, the company said.