The priority review status aids in reducing the regulator’s review period by four months.
Approval of crinecerfont would also allow Neurocrine to utilise its rare paediatric disease designation priority review voucher, which was awarded in September 2020.
In March 2019 and December 2023, crinecerfont received orphan drug and breakthrough therapy designations.
The FDA granted the breakthrough therapy status based on the results and safety profile of the asset in the Phase III CAHtalyst studies.
Neurocrine Biosciences chief medical officer Eiry Roberts said: “Receipt of a priority review reflects the FDA’s agreement that CAH is a serious condition and there is an urgent need for patients to have access to new treatments.
“Crinecerfont’s compelling efficacy results and excellent safety profile support our filing, and we look forward to working with the FDA as we head toward the PDUFA dates at the end of 2024.”
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