Sweden-based Camurus AB (Nasdaq Stockholm: CAMX) announced on that the US FDA has issued a Complete Response Letter (CRL) for a New Drug Application (NDA) related to CAM2029 (Oclaiz), an octreotide extended-release injection for the treatment of acromegaly. The CRL delays what had been an anticipated US market entry and extends the approval timeline by at least several months, though the company said it plans to resubmit an updated filing in the near term.
The FDA’s concerns are exclusively manufacturing-related. The CRL cites unresolved observations from a current Good Manufacturing Practice (cGMP) inspection conducted at a third-party contract manufacturer’s facility in September 2024. The FDA indicated that satisfactory resolution of those manufacturing deficiencies — which could require a reinspection of the facility — is a prerequisite for approval. The agency also recommended a labeling change related to the oxygen absorber component of the product packaging. The FDA cGMP inspection findings do not implicate the clinical profile of the drug, Camurus noting that the clinical data package supporting the NDA remains intact.
This is the second CRL Camurus has received for this NDA. The first was also issued solely on the basis of cGMP observations at the same third-party manufacturing facility, as disclosed when Camurus resubmitted the NDA in December 2025 and the FDA subsequently accepted the resubmission with a PDUFA target action date of June 10, 2026. The recurrence of a manufacturing-based CRL on the resubmission indicates that the FDA determined the corrective and preventive actions implemented since the September 2024 inspection were not yet sufficient to clear the application, or that a formal reinspection had not yet occurred.
The regulatory path for the Camurus NDA complete response letter situation has been shaped entirely by third-party manufacturing compliance issues rather than clinical data gaps. The ACROINNOVA Phase III clinical program — comprising ACROINNOVA 1 and ACROINNOVA 2 — provided a robust efficacy and safety dataset supporting the NDA. ACROINNOVA 2 reported positive 52-week results in July 2024, demonstrating statistically significant improvements in IGF-1 normalization, symptom control, and quality of life compared to standard-of-care somatostatin receptor ligands at baseline.
The product received marketing authorization in the EU and UK in 2025 under the brand name Oczyesa®, with commercial launch initiated in Germany. That approval was based on the same clinical dataset now under FDA review, providing a measure of regulatory validation for the clinical package outside the US.