The FDA has issued a Complete Response Letter (CRL) for Camurus’ new drug application (NDA) for CAM2029, an extended-release injection for treating acromegaly.
The CRL resulted from deficiencies found during a recent inspection of a third-party manufacturer. No concerns were raised regarding CAM2029’s clinical efficacy or safety.
Camurus is now collaborating with the FDA and the third-party manufacturer to address the inspection-related observations. Labeling discussions with the FDA had advanced before the CRL, and the prescribing information is well-developed.
The regulatory review for CAM2029 in the European Union is ongoing. Additionally, Camurus is advancing two development programs for CAM2029 to treat gastroenteropancreatic neuroendocrine tumors and polycystic liver disease unaffected by the CRL.
CAM2029 is a long-acting formulation of octreotide, a somatostatin analogue that works by binding to somatostatin receptors, primarily in the pituitary gland, to inhibit the excessive secretion of growth hormone (GH). By reducing GH levels, CAM2029 helps control the elevated insulin-like growth factor-1 (IGF-1) that drives the symptoms and complications of acromegaly.