Biopharmaceutical company Camurus (NASDAQ STO: CAMX) announced on Friday that it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Oczyesa, a long-acting octreotide subcutaneous depot (CAM2029), as maintenance therapy for adults with acromegaly who have responded to and tolerated somatostatin analogues.

Recommendation is based on data from seven clinical trials, including two Phase 3 studies. ACROINNOVA 1 showed Oczyesa significantly improves insulin growth factor-1 (IGF-1) levels over placebo, while ACROINNOVA 2 demonstrated sustained biochemical control, symptom relief, and improved quality of life over 52 weeks. Adverse events were consistent with standard treatments, primarily involving gastrointestinal, nervous system, and injection site reactions.

Final marketing authorisation by the European Commission is expected by mid-2025.

CAM2029, formulated using Camurus' proprietary FluidCrystal technology, is a once-monthly, room-temperature stable, self-administered injection. It offers five-fold higher bioavailability than intramuscular octreotide and has also received orphan drug designation in the EU for acromegaly and polycystic liver disease.

Acromegaly, a rare disorder caused by excess growth hormone from pituitary tumors, affects approximately 60 people per million and can significantly impair quality of life and increase mortality if left untreated.

Camurus, headquartered in Lund, Sweden, focuses on developing long-acting therapies for chronic and severe diseases using its FluidCrystal platform, with operations across Europe, the US and Australia.