FDA grants priority review for Neurocrine Neurocrine’s crinecerfont NDAs

2024-07-02

优先审批临床3期申请上市突破性疗法孤儿药

FDA grants priority review for Neurocrine’s crinecerfont NDAs

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来源: Pharmaceutical Technology

The asset is intended to treat congenital adrenal hyperplasia in paediatric and adult patients. Credit: YURIMA / Shutterstock.

The US Food and Drug Administration (FDA) has accepted Neurocrine Biosciences’ new drug applications (NDAs) for crinecerfont to treat classic congenital adrenal hyperplasia (CAH), and has granted priority review.

Crinecerfont is the first new CAH treatment option in paediatric and adult patients in seven decades.

The NDAs for crinecerfont include a capsule formulation (NDA# 218808) and an oral solution formulation (NDA# 218820).

The applications are supported by data from the CAHtalyst Pediatric and CAHtalyst Adult Phase III clinical trials.

A regulatory decision on the approvals for the asset is expected by 29 and 30 December 2024 respectively.

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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.”