FDA issues Complete Response Letter for Camurus’ CAM2029 (Oclaiz™) in acromegaly, citing third‑party manufacturing deficiencies and packaging modification. No concerns raised on efficacy or safety; EU and UK approvals remain intact.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Camurus’ New Drug Application (NDA) for CAM2029 (Oclaiz™), an extended-release octreotide injection for adults with acromegaly. The decision follows a September 2024 Current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility, where deficiencies were identified.
The FDA also requested a labeling modification related to the oxygen absorber component used in the product’s packaging. According to the agency, satisfactory resolution of the manufacturing observations, which may include a reinspection of the facility, is required before the NDA can be approved.
The CRL does not cite any concerns regarding CAM2029’s efficacy, safety, or overall clinical profile.
Clinical Evidence Remains Strong
CAM2029 is a once-monthly subcutaneous octreotide depot formulation administered through a prefilled autoinjector pen using Camurus’ FluidCrystal® technology. The therapy provides sustained growth hormone suppression and may reduce treatment burden compared with long-acting intramuscular depot injections.
The ACROINNOVA clinical program included seven studies spanning Phase 1 through Phase 3 development. CAM2029 demonstrated approximately five-fold higher bioavailability than intramuscular octreotide LAR and achieved superior biochemical control compared with placebo. The therapy also improved symptom control, treatment satisfaction, and quality-of-life measures in patients previously treated with first-generation somatostatin receptor ligands, including octreotide and lanreotide.
The safety profile remained consistent with established somatostatin receptor ligand therapies, with no new safety signals reported across the development program.
Treatment Landscape
Acromegaly is a rare endocrine disorder most commonly caused by growth hormone-secreting pituitary tumors. Excess growth hormone increases insulin-like growth factor-1 (IGF-1) levels, leading to progressive tissue overgrowth, metabolic complications, cardiovascular risks, and reduced quality of life.
Current treatment options include long-acting somatostatin receptor ligands such as octreotide LAR, lanreotide, and pasireotide. However, some patients continue to experience inadequate biochemical control or face challenges associated with chronic injection regimens. CAM2029 offers a subcutaneous, ready-to-use alternative to currently available long-acting injectable therapies.
Company Response
Camurus reported that its contract manufacturer has completed corrective and preventive actions addressing the inspection observations, submitted remediation updates to the FDA, and declared readiness for reinspection.
President and CEO Fredrik Tiberg said the company remains focused on resubmitting the NDA in the near term while maintaining commercial launch preparedness. He also noted that the regulatory delay does not alter the company’s financial outlook for 2026.
Path Forward
Following NDA resubmission, the FDA will assign a new Prescription Drug User Fee Act (PDUFA) target action date. Depending on the scope of the resubmission, the agency may conduct either a two-month or six-month review.
Outside the United States, CAM2029 has already secured marketing authorization in the European Union and the United Kingdom under the brand name Oczyesa®. Development programs evaluating the therapy in gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and polycystic liver disease remain unaffected by the FDA decision.
Broader Context
The latest CRL shifts the regulatory focus from clinical review to manufacturing compliance. With corrective actions reportedly completed, FDA acceptance of the facility remediation plan and any required reinspection will likely determine the timing of a future approval decision.
For CAM2029, the remaining path to U.S. approval appears to depend on resolution of facility-related deficiencies rather than additional clinical evaluation.
Reference
Camurus provides regulatory update on the US NDA for CAM2029 (Oclaiz™) in acromegaly – Camurus
About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.