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.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA