#Sweden #Lund #Camurus #Oczyesa #CHMP

Camurus Receives Positive Recommendation from CHMP for Oczyesa®

On April 25, 2025, Camurus, a biopharmaceutical company based in Lund, Sweden, announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the market approval of Oczyesa®, a long-acting octreotide subcutaneous depot (CAM2029). This groundbreaking medication is intended for the maintenance treatment of adult patients suffering from acromegaly who have previously responded positively to somatostatin analogues.

Enhancing Patient Care

Fredrik Tiberg, the President and CEO of Camurus, expressed his satisfaction with the CHMP's recommendation, highlighting the significant potential of Oczyesa to enhance the standard of care for acromegaly patients. He noted that this innovative treatment option will improve octreotide plasma exposure, allowing for a convenient once-monthly self-administration via an autoinjector pen.

Acromegaly is a rare but progressive disorder typically caused by a pituitary tumor that leads to excessive growth hormone production. This condition can result in abnormal growth of bones and tissues, leading to various health complications such as joint pain, fatigue, and increased risk of serious diseases. With an estimated prevalence of about 60 cases per million, effective treatment is crucial for improving patient quality of life and management of symptoms.

The CHMP's recommendation is based on a robust clinical program that includes seven clinical studies, of which two are Phase 3 trials. The ACROINNOVA 1 study demonstrated that Oczyesa significantly improved the likelihood of patients achieving normalized insulin growth-factor-1 (IGF-1) levels compared to a placebo. Additionally, the results from the ACROINNOVA 2 study indicated ongoing improvements in IGF-1 levels and symptom reduction over a span of 52 weeks.

Clinical Evidence and Safety Profile

The advancements offered by Oczyesa go beyond mere biochemical control. The ongoing studies have validated improvements in symptoms, quality of life, and patient satisfaction after a year of treatment when compared to standard care options. Notably, common side effects associated with this therapy include gastrointestinal issues, nervous system disorders, and injection site reactions, all consistent with the established safety profile of standard somatostatin-receptor ligands.

Anticipated Approval

Following the CHMP's favorable opinion, a final decision on Oczyesa’s marketing authorization is expected from the European Commission in mid-2025. This could signify a major step forward for the treatment landscape of acromegaly in Europe.

Understanding Oczyesa® (CAM2029)

Oczyesa is specifically developed as a ready-to-use, long-acting subcutaneous depot of octreotide, with applications beyond just acromegaly. It is also being investigated for the treatment of gastroenteropancreatic neuroendocrine tumors and polycystic liver disease. The formulation leverages Camurus' proprietary FluidCrystal® technology, allowing for once-monthly self-administration without the need for refrigeration.

Given its five-fold higher bioavailability compared to existing long-acting treatments, Oczyesa represents not only a significant improvement in patient adherence but also a compelling option for doctors managing chronic conditions.

About Camurus

Camurus is dedicated to advancing innovative therapies that address severe chronic diseases. With a focus on developing long-acting medications, the company utilizes its FluidCrystal® technology to underpin new treatment solutions. Operating across Europe, the United States, and Australia, Camurus is committed to improving patient lives through scientific breakthroughs.

With the positive momentum surrounding Oczyesa, many eyes remain fixed on the expected decision from the European Commission, as this breakthrough could reshape the treatment paradigm for patients with acromegaly across the EU.