Swedish research-based biotechnology company Camurus AB (STO: CAMX) announced on Monday the launch 0f Oczyesa in Germany, marking its first introduction in the European Union following marketing authorisation from the European Commission.
Oczyesa, a once-monthly subcutaneous octreotide depot, is approved for maintenance treatment in adults with acromegaly who have responded to somatostatin analogues. The medicine, based on Camurus' FluidCrystal technology, does not require refrigeration and allows self-administration via an autoinjector pen. It is designed to provide sustained disease control and improve patient quality of life.
Clinical studies have shown that Oczyesa offers sustained biochemical control and symptom relief, with a safety profile consistent with first-generation long-acting somatostatin receptor ligands.
Acromegaly is a rare chronic condition affecting an estimated 70,000 people in the EU. It is typically caused by a pituitary tumour leading to excess growth hormone and elevated insulin growth factor-1 levels, resulting in abnormal bone and tissue growth.
Oczyesa is also being developed for gastroenteropancreatic neuroendocrine tumours and polycystic liver disease, and Camurus says it plans further launches of Oczyesa across additional EU countries.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval