Camurus AB | MedPath

FDA Issues Complete Response Letter for Camurus' CAM2029 in Acromegaly

5 months ago

• The FDA issued a Complete Response Letter (CRL) for Camurus' CAM2029 (octreotide) extended-release injection for acromegaly due to manufacturing deficiencies. • The CRL is linked to a third-party manufacturer's cGMP inspection in September 2024, with no concerns about CAM2029's clinical efficacy or safety. • Camurus is collaborating with the FDA and the manufacturer to address the issues and expedite the drug's availability for acromegaly patients. • A Market Authorization Application for CAM2029 is under review in the EU, and development programs for other indications are ongoing.