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Panel To Weigh Amarin’s Expanded Vascepa Use Given Clinical Outcome Concerns

 
• By Sarah Karlin-Smith

FDA advisors will discuss Oct. 16 whether Vascepa’s effect on reducing triglycerides is enough to overcome concerns about this surrogate endpoint not panning out in other drug’s clinical outcomes trials.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will vote on whether the potential treatment effect of change in fasting triglycerides seen with Amarin Corp. PLC’s Vascepa (icosapent ethyl) is enough to grant it an expanded indication prior to the completion of a cardiovascular outcomes trial.

The lack of a completed outcomes study could be particularly controversial because other products approved based on a surrogate of...

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More from United States

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
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An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

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• By Sarah Karlin-Smith

HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.

More from North America

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.