Camurus AB (publ) announced that the US Food and Drug Administration (FDA) has accepted for review the company?s New Drug Application (NDA) for Oclaiz (CAM2029) for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 21 October 2024. AM2029 is a novel, octreotide subcutaneous depot designed for convenient, once-monthly self-administration, enhanced octreotide plasma exposure, and robust disease control.

The NDA for Oclaiz? for the treatment of patients with acromegaly is based on data from seven clinical studies, including two Phase 3 studies within the ACROINNOVA program.