#Sweden #Lund #Camurus #Oczyesa #Acromegaly

Camurus' Oczyesa® Granted EU Marketing Authorization for Acromegaly Treatment

In a significant advancement for patients suffering from acromegaly, Camurus (NASDAQ STO: CAMX) has announced that the European Commission (EC) has granted marketing authorization for Oczyesa®, an octreotide subcutaneous depot. This marks the first approval for a once-monthly octreotide treatment administered via subcutaneous injection for adult patients who have previously responded and tolerated somatostatin analog treatments.

Introduction to Oczyesa®

Founded with a vision to enhance patient care, Camurus is now set to introduce Oczyesa® across European markets. Fredrik Tiberg, the company’s President and CEO, expressed enthusiasm over this development, anticipating that patients will benefit from this convenient self-administration method, facilitated by a pre-filled autoinjector pen.

Acromegaly, a rare yet serious condition, is primarily caused by an abnormal growth hormone secretion from a pituitary tumor, leading to excessive growth of bones and tissues. The illness can result in pronounced symptoms, including enlarged extremities, facial features, and even significant internal organ growth. Additionally, it can severely impact patients' quality of life, leading to complications like joint pain, fatigue, headaches, and more.

The Clinical Significance of Oczyesa®

More than 70,000 individuals in the EU are believed to be living with this chronic disease. Notably, Oczyesa® has been unveiled as a groundbreaking treatment option that brings beneficial disease management and improved self-care capabilities to patients. Dr. Diego Ferone, a notable endocrinologist, commented on the welcome addition of Oczyesa® in the available treatment options, highlighting its positive impacts on symptom control and overall patient quality of life, as substantiated by data from the ACROINNOVA clinical program.

The approval of Oczyesa® is rooted in a robust clinical development program that includes seven pivotal studies, of which two were Phase 3 trials. Findings from the ACROINNOVA 1 study indicated that patients treated with Oczyesa® experienced a significantly higher normalization rate of insulin growth factor-1 (IGF-1) levels compared to those administered placebo treatments. Furthermore, improvements in symptoms and life quality were observed over a period of 52 weeks in the subsequent ACROINNOVA 2 study.

Safety Profile of Oczyesa®

As is customary with new medicinal products, safety considerations are paramount. Data suggests that the most commonly reported side effects of Oczyesa® may include gastrointestinal disturbances, nervous system complications, and injection site reactions. Nonetheless, the comprehensive safety profile aligns with expectations for similar treatment regimens currently in use.

Innovative Formulation Technology

At the heart of Oczyesa®'s formulation is Camurus' unique FluidCrystal® technology, designed to optimize patient convenience. The innovative product structure facilitates easy monthly administration without the necessity of refrigeration, making it suitable for various patient lifestyles.

Future Implications and Launch Plans

With marketing authorization in hand, Camurus is focused on expediting patient access to Oczyesa® throughout the EU. Plans for availability for eligible patients are underway, promising a new horizon in acromegaly management.

Camurus remains committed to addressing other chronic conditions with innovative products rooted in their extensive R&D capabilities. The company is also working on additional indications for CAM2029, including treatments for more severe ailments like gastroenteropancreatic neuroendocrine tumors.

As Europe anticipates the arrival of Oczyesa®, patients can hope for a transformative approach to managing a previously untreatable condition. This reflects the broader commitment of Camurus to improve the quality of life for those battling chronic diseases through pioneering medication solutions.

For more detailed information about Camurus and its pioneering treatments, visit Camurus official website.