- CHMP recommends approval of Oczyesa® for acromegaly treatment in EU
- Key trials show superior efficacy with higher IGF-1 normalization rates
- EU market authorization decision expected by mid-2025
Camurus (CAMX, Financial) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the market authorization of Oczyesa®, a monthly octreotide depot treatment for adult patients with acromegaly. This recommendation marks a crucial step towards full European Union (EU) approval, expected by mid-2025.
The CHMP's positive opinion is based on robust data obtained from seven clinical studies, including two pivotal Phase 3 trials. The ACROINNOVA 1 study highlighted that treatment with Oczyesa results in significantly higher normalization rates of insulin growth-factor-1 (IGF-1) levels compared to placebo. Moreover, the ACROINNOVA 2 study confirmed sustained IGF-1 improvements over 52 weeks, showing enhanced symptoms, quality of life, and treatment satisfaction when compared with standard care.
Oczyesa's innovation lies in its drug delivery mechanism, allowing for a once-monthly self-administration via a subcutaneous depot formulation. This development could potentially improve patient adherence, as current treatments often require healthcare professional administration. Common side effects reported include gastrointestinal, nervous system, and hepatobiliary disorders, aligning with the expected pharmacological profile of octreotide.
Camurus' Oczyesa represents a significant advancement in acromegaly treatment, offering improved hormone control and a patient-friendly administration option. The final decision by the European Commission on marketing authorization is anticipated in mid-2025, following this favorable CHMP recommendation.
