“We are pleased with the CHMP’s positive recommendation for market authorization for Oczyesa octreotide monthly depot for the treatment of acromegaly”, says Fredrik Tiberg, President & CEO at Camurus. “Oczyesa has the potential to advance the standard of care for patients living with acromegaly by enhancing octreotide plasma exposure and enabling easy and convenient once-monthly self-administration by patients using an autoinjector pen.”

Seven clinical studies

The CHMP positive opinion is backed by a comprehensive clinical program 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 normalized insulin growth-factor-1 (IGF-1) levels compared to placebo, describes the company. The persistence of mean IGF-1 values and reduction of symptoms were confirmed over 52 weeks in the ACROINNOVA 2 study. Furthermore, the study 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. The most common side effects included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.

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