FDA Rejects Camurus' Hormone Disorder Drug

The FDA has sent a Complete Response Letter (CRL) to Camurus regarding their New Drug Application (NDA) for CAM2029, an extended-release injection designed for treating acromegaly. This CRL was issued due to deficiencies identified during an inspection of a third-party manufacturing facility. Importantly, no issues were noted with the clinical efficacy or safety of CAM2029.

Camurus is currently working with both the FDA and the third-party manufacturer to address the concerns raised during the inspection. Prior to the issuance of the CRL, significant progress had been made in labeling discussions with the FDA, indicating that the prescribing information for CAM2029 is well-developed.

In the European Union, the regulatory review process for CAM2029 continues. Additionally, Camurus is progressing with two other development programs for CAM2029: one targets gastroenteropancreatic neuroendocrine tumors, and the other focuses on polycystic liver disease. These programs are proceeding unaffected by the recent CRL.

CAM2029 is a long-acting form of octreotide, a somatostatin analogue. It functions by binding to somatostatin receptors, mainly located in the pituitary gland, which helps inhibit the excessive secretion of growth hormone (GH). By lowering GH levels, CAM2029 aids in controlling the elevated insulin-like growth factor-1 (IGF-1), which is responsible for the symptoms and complications associated with acromegaly.