Camurus AB’s Oczyesa has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), marking a significant milestone for patients with acromegaly across the European Union.
Positive CHMP Opinion Secures Market Authorization
On April 25, 2025, CHMP endorsed the marketing authorization for Oczyesa, a 20 mg prolonged-release octreotide solution designed for injection using a pre-filled pen. This approval paves the way for the drug’s availability to adults requiring maintenance treatment for acromegaly, a rare hormonal disorder.
Clinical Efficacy and Safety Profile Confirmed
Clinical data from two phase 3 studies demonstrated that Oczyesa effectively reduces and often normalizes levels of insulin-like growth factor 1 (IGF-1) and growth hormone in patients. The first study was a 24-week randomized, double-blind, placebo-controlled multicenter trial, while the second encompassed a 52-week open-label multicenter study. The most common adverse effects reported included gastrointestinal and nervous system disorders, hepatobiliary issues, metabolic and nutritional disturbances, as well as injection site reactions.
Key Inferences:
- Oczyesa offers a convenient once-monthly injection schedule, enhancing patient compliance.
- Its formulation as a different salt of octreotide may provide improved tolerability over existing treatments.
- The orphan designation underscores the drug’s importance in addressing a rare, debilitating condition.
As a hybrid medicine, Oczyesa builds upon the established efficacy of Sandostatin, authorized in the EU since 1988. Its higher strength and distinct pharmaceutical form cater to patients who have achieved hormone level control with other somatostatin analogues, expanding therapeutic options within the acromegaly treatment landscape.
Post-approval, detailed usage guidelines will be available in the summary of product characteristics (SmPC), accessible in all EU languages. The European Commission will finalize the marketing authorization, ensuring widespread access to Oczyesa for those in need.
Camurus AB’s innovation with Oczyesa not only reinforces the company’s commitment to advancing treatments for rare diseases but also enhances the quality of life for acromegaly patients by providing an effective and manageable therapy option.
With Oczyesa’s approval, healthcare providers can now offer an additional, effective treatment pathway for managing acromegaly, potentially improving long-term outcomes and patient adherence through its user-friendly administration and robust safety profile.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
