(Reuters) -The U.S. Food and Drug Administration has approved Ionis Pharmaceuticals’ drug to treat a rare genetic disorder, making it the company’s first wholly-owned drug, the health regulator’s website showed on Thursday.
The drug, chemically known as olezarsen and branded as Tryngolza, is also the first approved treatment for familial chylomicronemia syndrome (FCS), a disorder that prevents the body from breaking down fats and is characterized by extremely high levels of triglycerides.
The company did not immediately respond to Reuters’ request for comment on pricing and availability.
FCS is caused by the deficiency or impaired function of the lipoprotein lipase enzyme, responsible for breaking down triglycerides — which lead to inflammation of the pancreas when accumulated in the blood.
A strict low-fat diet is the current first-line treatment for the condition.
The disorder affects fewer than 5,000 people in the U.S., according to government data.
(Reporting by Sriparna Roy, Kamal Choudhury and Mariam Sunny in Bengaluru; Editing by Shailesh Kuber and Alan Barona)
