(MedPage Today) -- The FDA approved olezarsen (Tryngolza) as the first drug for adults with familial chylomicronemia syndrome, a rare genetic disorder that can cause triglyceride levels to reach the thousands.
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TRYNGOLZA™ (olezarsen) approved in U.S. as first-ever treatment for adults living with familial chylomicronemia syndrome as an adjunct to diet

TRYNGOLZA shown to significantly reduce triglycerides and substantially reduce acute pancreatitis events in adults with FCS; a rare, highly debilitating and life-threatening diseaseIndicated for adults with FCS regardless of genetically or clinically confirmed diagnosis TRYNGOLZA is the first of four…

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First Drug Approved for Familial Chylomicronemia Syndrome

On December 19, 2024, Ionis Pharmaceuticals, Inc. made a significant announcement about the approval of Tryngolza™ (olezarsen) by the U.S. Food and Drug Administration (FDA). This approval marks a groundbreaking milestone as Tryngolza™ is now the first-ever treatment approved for adults suffering from familial chylomicronemia syndrome (FCS) in the United States as an adjunct to […]

themarketsdaily.com

Ionis Pharmaceuticals (IONS) Announces FDA Approval of Tryngolza™ for Treatment of Familial Chylomicronemia Syndrome

The rare genetic disease is a severe hypertriglyceridemia that can lead to potentially life-threatening acute pancreatitis.

Pharmacy Times

FDA Approves Olezarsen as Adjunct to Diet for Familial Chylomicronemia Syndrome

The US FDA has approved Ionis' TRYNGOLZA (olezarsen) as an adjunct to diet for reducing triglyceride levels in the adult population with FCS

pharmaceutical-technology.com

FDA approves Ionis’ TRYNGOLZA for FCS treatment

The clearance of Tryngolza gives Ionis its first wholly-owned, marketed medicine. Elsewhere, Robert Temple became the latest FDA leader to leave the agency, and two biotechs cut research deals.

biopharmadive.com

Ionis gets a milestone approval; Another top FDA official to step down

Tryngolza is once-monthly, subcutaneous RNA-targeted therapy and is expected to be available by the end of the year with a price of $595,000.

Managed Healthcare Executive

FDA Approves Tryngolza for Rare Cholesterol Disease

Ionis Pharmaceuticals has reached a significant milestone with the FDA’s approval of Tryngolza (olezarsen), a groundbreaking treatment for familial chylomicronemia syndrome (FCS), a rare genetic disorder that impairs fat breakdown in the body. This approval signifies a pivotal moment for Ionis, as Tryngolza is the first drug the company will commercialize independently, marking a departure from its previous strategy of partnering with other comp…

First Drug Approved for Familial Chylomicronemia Syndrome

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