Oczyesa approved for acromegaly
Camurus announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for market authorization of Oczyesa, octreotide subcutaneous depot (CAM2029), for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.
Camurus announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for market authorization of Oczyesa, octreotide subcutaneous depot (CAM2029), for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues. A final decision on the marketing authorization of Oczyesa based on the CHMP recommendation is anticipated from the European Commission in mid-2025.
The CHMP positive opinion is backed by a comprehensive clinical program comprising seven clinical studies, including two Phase III 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. 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.
“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.”
See citatiion- Ferone D , SilversteinJ , Freda P et al. 7373 CAM2029, Octreotide Subcutaneous Depot, Provides Sustained Biochemical Control of Acromegaly: Interim Results From a Phase 3 Study (ACROINNOVA 2), J Endocr Soc . 2024, 8(Suppl 1) :bvae163.1155. doi: 10.1210/jendso/bvae163.1155
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