FDA Accepts Resubmitted CAM2029 NDA for Acromegaly

The US Food and Drug Administration (FDA) has accepted Camurus’ resubmitted new drug application (NDA) for CAM2029, an investigational once-monthly subcutaneous octreotide depot for patients with acromegaly.1

Announced on July 16, 2026, by parent company Camurus, the agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 18, 2026.1

The filing follows a complete response letter (CRL) issued June 10, 2026, which cited observations from a current good manufacturing practice inspection of a third-party manufacturer. Camurus reported that no concerns involving clinical efficacy or safety were identified in the letter and said that the manufacturer completed remediation measures.1

“We look forward to continuing the collaboration with the FDA to make CAM2029 available to patients with acromegaly in the United States,” Fredrik Tiberg, president and chief executive officer of Camurus, said in a statement.1

Why FDA Previously Declined the CAM2029 Application

According to Camurus, the June CRL focused on manufacturing inspection observations rather than the clinical data package. The company said its contract manufacturer has completed corrective actions and confirmed readiness for inspection.1

The NDA is supported by 7 clinical studies: 4 phase 1 studies, 1 phase 2 study, and 2 phase 3 studies from the ACROINNOVA program. CAM2029 is formulated using Camurus’ FluidCrystal drug-delivery technology and is designed for once-monthly self-administration with a prefilled autoinjector.1

CAM2029 is already authorized for acromegaly in the European Union and the United Kingdom under the name Oczyesa. European product information describes it as a prolonged-release octreotide formulation administered subcutaneously every 4 weeks. Marketing applications are also under review in 2 additional countries, according to Camurus.1,2

In the United States, long-acting octreotide is currently available as Sandostatin LAR Depot, an intramuscular formulation indicated for patients with acromegaly who have responded to and tolerated subcutaneous octreotide. Octreotide is a somatostatin analogue; its pharmacologic activity includes suppression of growth hormone secretion.3

What the ACROINNOVA Phase 3 Program Reported

ACROINNOVA 1 was a randomized, double-blind, placebo-controlled phase 3 trial evaluating subcutaneous octreotide depot in acromegaly. Camurus characterized the trial as showing superior biochemical control over placebo. The company also reported improvements in symptoms, treatment satisfaction, and quality of life across the broader phase 3 program compared with baseline assessments during treatment with first-generation somatostatin receptor ligands, including octreotide and lanreotide. Additionally, Camurus described the safety profile as consistent with existing somatostatin receptor ligand therapy, with no new findings.1,4

Acromegaly most often arises from a growth hormone–secreting pituitary tumor and produces elevated insulin-like growth factor 1 concentrations. Persistent biochemical activity is associated with progressive systemic complications, impaired quality of life, and excess mortality. Camurus cited an estimated prevalence of approximately 60 cases per million people.1

The immediate regulatory question concerns whether the manufacturing deficiencies cited in June have been adequately resolved. No additional clinical studies were announced as part of the resubmission. The FDA decision expected in December will apply only to the proposed US indication and formulation.1

References

1. Camurus’ NDA resubmission for CAM2029 in acromegaly accepted for review by the US FDA. PR Newswire. July 16, 2026. https://www.prnewswire.com/news-releases/camurus-nda-resubmission-for-cam2029-in-acromegaly-accepted-for-review-by-the-us-fda-302828303.html

2. Oczyesa: EPAR product information. European Medicines Agency. https://edge.prnewswire.com/c/link/?t=0&l=en&o=4733797-1&h=3228323740&u=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fproduct-information%2Foczyesa-epar-product-information%5Fen.pdf&a=SmPC+Oczyesa%C2%AE

3. Sandostatin LAR Depot prescribing information. US Food and Drug Administration. https://edge.prnewswire.com/c/link/?t=0&l=en&o=4733797-1&h=4289552022&u=https%3A%2F%2Fwww.accessdata.fda.gov%2Fdrugsatfda%5Fdocs%2Flabel%2F2024%2F021008s049lbl.pdf&a=Prescribing+Information+SANDOSTATIN%C2%AE+LAR

4. Ferone D, et al. Octreotide subcutaneous depot for acromegaly: a randomized, double-blind, placebo-controlled phase 3 trial, ACROINNOVA 1. J Clin Endocrinol Metab. Published October 8, 2024. https://edge.prnewswire.com/c/link/?t=0&l=en&o=4733797-1&h=762902397&u=https%3A%2F%2Fdoi.org%2F10.1210%2Fclinem%2Fdgae707&a=https%3A%2F%2Fdoi.org%2F10.1210%2Fclinem%2Fdgae707