Swedish biopharmaceutical company Camurus (STO:CAMX) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for market authorisation of Oczyesa, octreotide subcutaneous depot (CAM2029), for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

CAM2029 is a ready-to-use, long-acting subcutaneous depot of octreotide under development for the treatment of three chronic and severe disease indications: acromegaly, gastroenteropancreatic neuroendocrine tumours (GEP-NET) and polycystic liver disease (PLD).

The company said that the CHMP positive opinion was backed by a comprehensive clinical programme comprising seven clinical studies, including two Phase 3 studies. The ACROINNOVA 1 study demonstrated that treatment with Oczyesa results in a significantly higher proportion of patients achieving normalised insulin growth-factor-1 (IGF-1) levels compared to placebo. The persistence of mean IGF-1 values and reduction of symptoms were confirmed over 52 weeks in the ACROINNOVA 2 study. This study also showed improvements in symptoms, quality of life and treatment satisfaction scores after 52 weeks of treatment with Oczyesa compared to standard of care (SoC) at study baseline.

A final decision on the marketing authorisation of Oczyesa based on the CHMP recommendation is anticipated from the European Commission in mid-2025.