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.

CAM2029 is a novel, octreotide subcutaneous depot designed for once-monthly self-administration, enhanced octreotide plasma exposure, and robust disease control.

A milestone

“FDA’s acceptance of the NDA submission for Oclaiz marks a milestone in our efforts to develop a new, effective treatment for patients with acromegaly with the potential for reduced treatment burden and increased quality of life,” says Fredrik Tiberg, President & CEO, Camurus. “We are looking forward to working with the Agency during the registration process.”

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.

Photo of Fredrik Tiberg: Max Alm-Norell