Ionis Gets FDA Approval for Rare Disease Drug Tryngolza [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
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Source: Yahoo! Finance
approved its RNA-targeted therapy, olezarsen, in adults with familial chylomicronemia syndrome (FCS). The drug will be marketed under the trade name Tryngolza. The FDA's nod to Tryngolza makes it the first approved treatment for FCS in the country. The drug's commercial launch is part of management's broad strategy to deliver a steady flow of wholly-owned medicines to patients. Besides being Ionis' first wholly-owned drug, Tryngolza marks the company's first independent commercial launch, expected before this year's end. The approval is supported by results from the phase III BALANCE study, where FCS patients treated with olezarsen achieved significant triglyceride-lowering and substantial reductions in acute pancreatitis attacks in FCS patients. A regulatory filing for the drug is currently under review by the EMA, also supported by data from this study. FCS is a rare genetic disease marked by extremely elevated triglyceride levels. People living with this condition are at high
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