Camurus Receives Green Light for Oczyesa® to Treat Acromegaly in the UK

Camurus Announces Approval of Oczyesa® for Acromegaly Treatment in the UK

Lund, Sweden - Camurus, a biopharmaceutical firm listed on Nasdaq Stockholm under the ticker CAMX, has achieved a significant milestone with the approval of its drug, Oczyesa®, by the UK Medicines and Healthcare products Regulatory Agency (MHRA). This approval denotes that Oczyesa® can be utilized for maintenance treatment in adult patients suffering from acromegaly who have previously responded to and tolerated therapies involving somatostatin analogs.

Oczyesa®, a depot formulation of octreotide, is notable for being the first subcutaneous treatment delivered once a month. Fredrik Tiberg, Camurus’ President and CEO, emphasized the treatment's effectiveness in achieving sustained control over acromegaly symptoms while being easy for patients to administer independently using an autoinjector pen. The official market launch is anticipated in the UK during the fourth quarter of 2025, further enhancing treatment options available for those affected by this rare condition.

Clinical Background and Research

The approval from the MHRA came after an extensive clinical program that featured seven studies, including two pivotal Phase 3 trials as part of the ACROINNOVA program. These trials demonstrated the efficacy of Oczyesa® in managing acromegaly, illustrating its potential to normalize insulin growth-factor-1 (IGF-1) levels and alleviate the often debilitating symptoms endured by patients.

Acromegaly is attributed largely to tumors on the pituitary gland, resulting in excess growth hormone production. This advancement leads to various health issues including abnormal bone and tissue growth, alongside physical changes such as enlarged facial features and hands. Moreover, patients experience symptoms like fatigue, joint pain, and complications affecting quality of life.

The innovative FluidCrystal® technology used in Oczyesa® allows for a simple and effective once-monthly self-administration protocol, making it a convenient option compared to current treatments requiring frequent visits to healthcare facilities. The studies not only confirmed the safety profile of Oczyesa® but also noted a favorable response rate concerning symptom management, thus illustrating its broad potential for improving patient well-being.

Ongoing Development

In addition to treating acromegaly, Camurus is pursuing additional indications for CAM2029, including gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD). These efforts reflect the company’s commitment to expanding its portfolio of long-acting therapeutic options, specifically designed to make significant differences in the lives of patients enduring chronic conditions.

Conclusion

The arrival of Oczyesa® marks an exciting development for patients suffering from acromegaly in the UK. As Camurus prepares for its market entry, the biopharmaceutical industry watches closely. The implications of this approval extend beyond treatment; they highlight the importance of ongoing research and innovation aimed at combating rare diseases. By providing a versatile, patient-friendly treatment option, Camurus is contributing significantly to the advancement of patient care in endocrinology.

For additional information, contact:

- Fredrik Tiberg, President, CEO | Tel. +46 (0)46 286 46 92 | Email: [email protected]
- Fredrik Joabsson, Chief Business Development Officer | Tel. +46 (0)70 776 17 37 | Email: [email protected]