FDA Accepts Resubmission of Camurus' CAM2029 NDA for Acromegaly, Sets December 2026 PDUFA Date
核心洞察
The FDA has accepted Camurus (搜索)' resubmitted NDA for CAM2029 (octreotide extended-release injection) for acromegaly (搜索), assigning a PDUFA target action date of December 18, 2026.
The resubmission follows a prior Complete Response Letter related to cGMP manufacturing inspection observations at a third-party facility, which have since been resolved.
The CRL did not raise any concerns regarding the clinical efficacy or safety of CAM2029, which is already approved in the EU and UK under the brand name Oczyesa®.
Lund, Sweden-based Camurus (搜索) (NASDAQ STO: CAMX) announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for CAM2029 (Oclaiz™), an octreotide extended-release injection for the treatment of acromegaly (搜索). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 18, 2026.
The acceptance marks a significant step forward after the FDA issued a Complete Response Letter (CRL) in June 2026. The CRL stemmed from observations made during a September 2024 cGMP inspection at a third-party contract manufacturer and included a recommendation for a labeling change to the oxygen absorber component of the product packaging. Critically, the CRL did not raise any issues related to the clinical efficacy or safety profile of CAM2029.
"The CRL is disappointing. We are working toward resubmission of the NDA in the near term, while maintaining launch readiness and with no change to our 2026 financial outlook," said Fredrik Tiberg, Camurus (搜索)' President & CEO, at the time of the CRL announcement. "Camurus will continue to work closely with the Agency to bring CAM2029 to patients with acromegaly (搜索) in the United States."
The contract manufacturer has since implemented corrective and preventive actions addressing the inspection observations, provided the FDA with updates on remediation progress, and declared its inspection readiness. The FDA's acceptance of the resubmission indicates that the agency considers the response sufficiently complete to proceed with review.
Clinical Profile and Phase 3 Data
CAM2029 is a subcutaneous depot formulation of octreotide designed for enhanced drug exposure and convenient once-monthly self-administration using a prefilled autoinjector pen. The clinical development program for acromegaly (搜索) encompasses seven trials, including four Phase 1 studies, one Phase 2 study, and two Phase 3 studies within the ACROINNOVA clinical program.
CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to currently approved long-acting intramuscular octreotide formulations. In the Phase 3 ACROINNOVA program, CAM2029 showed superior biochemical control compared to placebo, as well as improvements in symptom control, treatment satisfaction, and quality of life compared to standard of care with first-generation somatostatin receptor (搜索) ligands (SRLs), including octreotide and lanreotide. The safety profile was consistent with standard of care, with no new safety findings reported.
Regulatory Status and Broader Pipeline
CAM2029 has already been granted marketing authorization for acromegaly (搜索) in the European Union and the United Kingdom under the brand name Oczyesa®. The CRL and subsequent resubmission do not impact the advancement of CAM2029 in other indications, including gastroenteropancreatic neuroendocrine tumors (搜索) (GEP-NET) and polycystic liver disease (搜索) (PLD), which remain under development.
Disease Background
Acromegaly (搜索) is a rare, slowly progressive disease typically caused by a pituitary gland tumor producing excess growth hormone, which stimulates increased insulin-like growth factor-1 (IGF-1) levels. This hormonal excess results in abnormal growth of bone and tissue, enlarged hands, feet, facial features, and internal organs, along with symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia. Inadequate biochemical and symptom control can have a detrimental impact on quality of life and mortality. The prevalence of acromegaly is estimated at approximately 60 cases per million.
The FDA review outcome will determine whether CAM2029 becomes available to acromegaly (搜索) patients in the United States market, with a decision expected by the December 18, 2026 PDUFA date.