FDA Approves Ocelot Bio’s Drug Treatment for Ascites

Ocelot Bio’s primary drug prospect, OCE-205, has received a rare drug designation from the U.S. Food and Drug Administration for the treatment of ascites, not including instances linked to cancer. 

Ascites is the atypical build-up of fluid in the abdominal cavity, often caused by liver cirrhosis, cancer, heart failure, or other underlying medical conditions. 

In early testing, OCE showed promise in reducing blood pressure within the portal venous system and in abdominal fluid build-up, suggesting its potential to manage issues related to advanced cirrhosis. 

Lise Kjem, the head medical executive at Ocelot Bio, commented, “The FDA granting orphan drug designation for OCE-205 in ascites is a validation of the tremendous need for improved therapies offering novel approaches for patients.” 

Kjems went on to add, “This milestone serves as a catalyst as we work with patients, healthcare professionals and health authorities to pave a brighter path forward for these patients who have limited treatment options.” 

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