FDA Accepts Camurus' Resubmitted NDA for Oclaiz Acromegaly Treatment with June 2026 PDUFA Date
核心洞察
The FDA has accepted Camurus (搜索)' resubmitted New Drug Application for Oclaiz (CAM2029), a monthly subcutaneous octreotide injection for acromegaly (搜索) treatment, with a PDUFA target action date of June 10, 2026.
The resubmission follows a Complete Response Letter that addressed manufacturing facility inspection issues, while the drug has already received marketing authorization in the EU and UK under the name Oczyesa.
Clinical data from seven studies, including two Phase 3 ACROINNOVA trials, demonstrated five-fold higher bioavailability compared to current intramuscular octreotide and significantly higher rates of normalized IGF-1 (搜索) levels.
The U.S. Food and Drug Administration has accepted for review Camurus (搜索)' resubmitted New Drug Application for Oclaiz (CAM2029), an octreotide extended-release injection for treating acromegaly (搜索) patients. The FDA assigned a Prescription Drug User Fee Act target action date of June 10, 2026, marking a significant regulatory milestone for the Swedish biopharmaceutical company.
"We look forward to the continued collaboration with the FDA to make Oclaiz available to patients with acromegaly (搜索) in the US as soon as possible," said Fredrik Tiberg, President & CEO of Camurus (搜索).
Enhanced Bioavailability and Convenience
Oclaiz represents a subcutaneous long-acting octreotide depot designed for optimized disease control and convenient self-administration. The product utilizes Camurus (搜索)' proprietary FluidCrystal technology and is administered once monthly through an autoinjector pen. Clinical studies have demonstrated that CAM2029 achieves approximately five-fold higher bioavailability compared to currently approved long-acting intramuscular octreotide formulations.
The comprehensive clinical program supporting the application includes seven clinical studies, comprising four Phase 1 studies, one Phase 2 study, and two pivotal Phase 3 studies within the ACROINNOVA program. The ACROINNOVA 1 study demonstrated that CAM2029 treatment resulted in a significantly higher proportion of patients achieving normalized insulin growth factor-1 (搜索) levels compared to placebo.
Sustained Clinical Benefits
The ACROINNOVA 2 study confirmed the persistence of mean IGF-1 (搜索) values and symptom reduction over 52 weeks of treatment. Additionally, the study showed reduced disease symptoms, improved quality of life, and enhanced treatment satisfaction scores after 52 weeks of CAM2029 treatment compared to standard of care at baseline. The most common side effects included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.
Regulatory Path Forward
The updated NDA was submitted to the FDA on December 10, 2025, following a Complete Response Letter issued by the Agency. The CRL solely related to observations during a cGMP inspection at a third-party manufacturer's facility, indicating that the clinical and regulatory issues had been previously resolved.
Oclaiz has already received marketing authorization in the European Union and United Kingdom in 2025 under the product name Oczyesa, with product launch recently initiated in the EU market.
Addressing Unmet Medical Need
Acromegaly (搜索) is a rare, slowly progressive disease typically caused by a pituitary gland tumor that produces excess growth hormone, stimulating increased insulin growth factor-1 (搜索) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and internal organs, along with symptoms including fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia. The prevalence of acromegaly is estimated at approximately 60 cases per million people.
Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality in patients with acromegaly (搜索), highlighting the importance of effective treatment options.
Broader Development Pipeline
Beyond acromegaly (搜索), CAM2029 is under development for two additional chronic and severe disease indications: gastroenteropancreatic neuroendocrine tumors (搜索) and polycystic liver disease (搜索), potentially expanding its therapeutic utility across multiple rare disease areas.