Camurus announced that the European Medicines Agency (EMA) has accepted for review the company's Market Authorisation Application (MAA) for octreotide subcutaneous (SC) depot (CAM2029) for the treatment of patients with acromegaly. The acceptance follows the MAA submission done end of April 2024 and marks the beginning of the formal review procedure. CAM2029 is a novel, octreotide subcutaneous depot designed for convenient, once-monthly self-administration by patients and enhanced octreotide plasma exposure with the potential for effective disease control and improved quality of life of patients.

The MAA submission for CAM2029 is supported by data from seven clinical trials, including two Phase 3 studies within the ACROINNOVA program.1,2 A new drug application for CAM2029 has earlier been submitted to the US Food and Drug Administration (FDA), and is currently under review with a PDUFA action date of 21 October 2024. CAM2029 for the treatment of acromegaly has been granted orphan drug designation status in the EU.