Key Goals Met in Phase 3 Study
Ionis Pharmaceuticals announced on Tuesday that its olezarsen drug candidate has achieved key goals in a Phase 3 study involving familial chylomicronemia syndrome, a rare genetic disorder. With these positive results, the company is now set to move forward with planned regulatory filings.
Significant Reduction in Triglyceride Levels
The study demonstrated that the olezarsen 80-milligram monthly dose led to a statistically significant reduction in triglyceride levels compared to the placebo. Moreover, this triglyceride-lowering effect continued to improve even at the 12-month mark.
Dramatic Decrease in Acute Pancreatitis Events
Another noteworthy finding was that the olezarsen 80-milligram dose exhibited a 100% reduction in acute pancreatitis events compared to the placebo, which serves as a significant secondary endpoint for the study.
Seeking Regulatory Approval
Ionis Pharmaceuticals has announced its intention to file for approval from both the U.S. Food and Drug Administration and the European Union early next year. The approval of olezarsen would mark a significant milestone as it would become the first available treatment in the U.S. for familial chylomicronemia syndrome, a disorder that can lead to acute, potentially fatal pancreatitis attacks.
Our Latest News
The Future of Farming: Embracing Technology to Feed the World
Agriculture is embracing technology to feed the world, with Deere's innovations in precision farming and electric excavators at CES 2022. Learn more about these...
Ralph Lauren's Strong Holiday Season Performance
Ralph Lauren reports impressive Q3 results, exceeding estimates and experiencing solid growth. CEO credits success to direct-to-consumer channels.
Warren Buffett's Doubts: The Fate of Paramount Global
Berkshire Hathaway sold more stock than it purchased in the second quarter, raising questions about the fate of Paramount Global. Learn more about Warren Buffet...