#Sweden #Lund #Camurus #Oczyesa #Acromegaly

Camurus’ Oczyesa® Receives EU Marketing Authorization for Acromegaly Treatment

In a significant milestone for endocrine treatment, Camurus (NASDAQ STO: CAMX) recently announced that the European Commission (EC) has granted marketing authorization for Oczyesa®, a novel subcutaneous depot formulation of octreotide. This therapy is specifically designed to provide maintenance treatment for adult patients suffering from acromegaly who have shown responsiveness to and can tolerate somatostatin analogs.

According to Fredrik Tiberg, the President and CEO of Camurus, "Oczyesa is the first approved once-monthly, subcutaneous octreotide treatment for patients with acromegaly." The company is eager to make this innovative treatment option available to the eligible patient population in the EU as swiftly as possible, highlighting the growing focus on patient-centered care.

Understanding Acromegaly

Acromegaly is a rare but chronic condition often caused by an adenoma in the pituitary gland, resulting in excessive production of growth hormone. This overproduction leads to an increase in insulin-like growth factor 1 (IGF-1), causing abnormal enlargement of bones and tissues, particularly in the hands, feet, and facial features. Patients often experience debilitating symptoms including fatigue, headaches, joint pain, and increased risk of life-threatening conditions. With an approximate prevalence of 70,000 cases across the EU, acromegaly profoundly impacts the quality of life of those affected.

Dr. Diego Ferone, a leading expert in endocrinology and head of the Department of Internal Medicine at the Ospedale Policlinico San Martino, University of Genoa, Italy, expressed optimism about Oczyesa, stating, "This is a welcome new treatment option for patients with acromegaly, providing effective disease control and enabling convenient self-administration by patients." This feature is especially crucial, considering the complexity of managing a chronic disease such as acromegaly.

Clinical Research and Results

The authorization for Oczyesa is grounded in a robust clinical program, which included seven clinical studies, with two pivotal Phase 3 trials at its core. The first phase of this program, known as ACROINNOVA 1, demonstrated a significantly higher percentage of patients achieving normalized IGF-1 levels compared to placebo. The follow-up ACROINNOVA 2 study further validated the benefits of Oczyesa by reporting sustained improvements in IGF-1 levels and symptom management over a 52-week treatment period. Additionally, quality of life assessments showed marked improvement, with patients reporting increased satisfaction compared to those on standard care.

Oczyesa utilizes Camurus' proprietary FluidCrystal® technology, facilitating a once-monthly subcutaneous self-injection. This pre-filled autoinjector allows patients to easily manage their treatment from the comfort of their homes, reducing the need for frequent hospital visits.

The clinical trials assessing Oczyesa have established a favorable safety profile, similar to that of existing treatments, with the most common adverse effects being mild and manageable gastrointestinal disturbances and injection site reactions.

Moving Forward

As the only subcutaneous octreotide treatment approved for acromegaly that can be self-administered monthly, Oczyesa not only adds a valuable option to the existing treatment landscape but also aligns with the increasing demand for patient-friendly therapies. Camurus plans to expedite the rollout of Oczyesa across Europe to ensure that patients can benefit from this innovative treatment without delay.

In summary, with the EU's approval of Oczyesa®, Camurus is set to transform the management of acromegaly, empowering patients with a novel, convenient treatment that promises greater control over their health outcomes. Patients and healthcare providers alike can look forward to improved quality of life and disease management in the coming years.