1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Ionis 12-Month FCS Data Position Olezarsen For Near-Term Filing

 
• By Joseph Haas

Showing its antisense drug can reduce triglycerides and risk of acute pancreatitis in familial chylomicronemia syndrome, Ionis plans to file olezarsen for approval soon, hoping for accelerated approval.

Ionis's 12-month data strengthen rationale for olezarsen in FCS

After reporting the full dataset from the Phase III BALANCE study of olezarsen in familial chylomicronemia syndrome (FCS) at the American College of Cardiology meeting, Ionis Pharmaceuticals, Inc. told an investor call on 8 April that it expects to file the ligand-conjugated antisense (LICA) candidate for US approval imminently, with approval possibly before the end of the year.

Key Takeaways

  • Building on topline data reported last year, Ionis reveals that olezarsen reduces triglyceride levels and risk of pancreatitis over 12 months in a Phase III study.

The data presented on 7 April at the ACC annual meeting in Atlanta built upon topline data from the 66-patient...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 
• By Andrew McConaghie

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By Manas Mishra

Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.

AZ Poised To Bring Self-Administered C5 Inhibitor To Market

 
• By Jessica Merrill

Gefurulimab will give AstraZeneca a new option to compete against Argenx’s Vyvgart Hytrulo, which is available subcutaneously.

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
• By Kevin Grogan

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.

More from R&D

AZ Poised To Bring Self-Administered C5 Inhibitor To Market

 
• By Jessica Merrill

Gefurulimab will give AstraZeneca a new option to compete against Argenx’s Vyvgart Hytrulo, which is available subcutaneously.

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
• By Kevin Grogan

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.

Obesity Beyond GLP-1s: Amylins – The Next Frontier

 
• By Aakash Babu

In this series of articles, we look at different mechanisms of actions beyond GLP-1s that could determine the obesity drug landscape in the coming years. First on our list – amylin receptor agonists, which analysts expect to grow into a $50bn market opportunity.