US FDA Accepts Camurus Resubmission for Acromegaly Drug CAM2029
The US Food and Drug Administration has officially accepted the resubmitted New Drug Application for CAM2029, a long-acting octreotide treatment for acromegaly. Following this procedural step, the agency has established a target action date of December 18, 2026, for the final regulatory decision on the Swedish firm's candidate.
This regulatory milestone follows a Complete Response Letter issued by the FDA on June 10, 2026. That initial rejection stemmed solely from observations regarding a cGMP inspection at a third-party manufacturing facility, rather than any deficiencies in the drug's clinical efficacy or safety profile. According to Camurus, the contract manufacturer has since completed all necessary remediation actions and confirmed its readiness for a follow-up assessment.
CAM2029, which utilizes the company's proprietary FluidCrystal technology, is designed as a once-monthly self-administered injection. The application is underpinned by data from seven clinical studies, including the late-stage ACROINNOVA program, which demonstrated superior biochemical control and patient quality of life compared to existing standard treatments. The drug is already authorized for use in the European Union and the United Kingdom under the brand name Oczyesa.
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