Business
Camurus announces approval of Oczyesa® for the treatment of acromegaly in the UK
Camurus (NASDAQ STO: CAMX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Oczyesa®, octreotide subcutaneous depot, marketing authorization for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs.1
About this update from Camurus Ab
[{"type":"text","content":"LUND, Sweden, Aug. 28, 2025 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Oczyesa®, octreotide subcutaneous depot, marketing authorization for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs.1","length":373,"tagName":"p"},{"type":"text","content":""Oczyesa, the first once-monthly subcutaneous octreotide treatment, has shown effective and sustained control of acromegaly and can be self-administered by patients using an autoinjector pen", says Fredrik Tiberg, President & CEO, CSO at Camurus. "Camurus plans to launch the treatment in the UK in the fourth quarter of 2025."","length":351,"tagName":"p"},{"type":"text","content":"The MHRA's marketing authorization of Oczyesa is based on the results from a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies within the ACROINNOVA program.","length":207,"tagName":"p"},{"type":"text","content":"Oczyesa is formulated using Camurus' proprietary FluidCrystal® technology. The product is designed for convenient once-monthly, subcutaneous self-administration using a pre-filled autoinjector pen with a hidden, thin needle.","length":228,"tagName":"p"},{"type":"text","content":"Oczyesa was granted marketing authorization in the EU by the European Commission on 30 June 2025.","length":97,"tagName":"p"},{"type":"text","content":"For more informationFredrik Tiberg, President & CEOTel. +46 (0)46 286 46 [email protected]","length":108,"tagName":"p"},{"type":"text","content":"Fredrik Joabsson, Chief Business Development OfficerTel. +46 (0)70 776 17 [email protected]","length":92,"tagName":"p"},{"type":"text","content":"About acromegalyAcromegaly is a rare, progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia.2 Inadequate biochemical and symptom control can have detrimental impacts on quality of life and m...