The FDA’s request concerns observations made during a cGMP inspection of a contract manufacturer in September 2024. According to Camurus, the agency said the issues must be satisfactorily addressed, which may include a new inspection of the manufacturing facility, before the application can be approved. The FDA also proposed a change to the labeling of an oxygen absorber in the product packaging.

Camurus said the letter does not raise concerns about the clinical efficacy or safety of CAM2029. The contract manufacturer has implemented corrective and preventive actions related to the 2024 inspection findings, has kept the FDA informed of its remediation work, and has confirmed its readiness for a reinspection.

“The CRL is disappointing. We are working to submit an updated NDA in the near term, while maintaining our launch readiness, with no changes to our financial guidance for 2026,” said Fredrik Tiberg, president and CEO of Camurus. “Camurus continues to work closely with the FDA to make CAM2029 available to patients with acromegaly in the US.”

A new PDUFA date will be assigned once the FDA accepts the updated application for review, with either a two- or six-month review cycle. Camurus noted that the CRL does not affect development of CAM2029 in gastroenteropancreatic neuroendocrine tumors or polycystic liver disease.

CAM2029 is already approved for acromegaly in the EU and the UK.