Camurus (CAMX), Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending market authorization of Oczyesa, its octreotide subcutaneous depot, for maintenance therapy in adults with acromegaly who have previously responded to somatostatin analogues.
Fredrik Tiberg, President & CEO of Camurus, noted that Oczyesa's monthly autoinjector pen could improve patient care by maintaining higher octreotide plasma levels and simplifying self-administration.
The CHMP endorsement is supported by a seven-study clinical program, including Phase 3 ACROINNOVA 1 and 2 trials, which demonstrated sustained normalization of insulin-like growth factor-1, symptom reduction, and enhanced quality of life over 52 weeks. Common adverse events included gastrointestinal, nervous system, hepatobiliary, metabolic disorders, and injection site reactions.
A final European Commission decision is expected by mid-2025.
CAMX is currently trading at $59.98 on the OTC Markets.
For comments and feedback: editorial@rttnews.com