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“Marginal” Mortality Benefit Belongs In Eliquis’ Label, But Not The Indication Statement, FDA Says

 
• By Sue Sutter

Although apixaban demonstrated a significant benefit on all-cause mortality in the ARISTOTLE trial, the statistical fragility of the finding meant the data were relegated to the label’s Clinical Studies section.

Pivotal trial data suggesting a survival advantage with Bristol-Myers Squibb Co./Pfizer Inc.’s Eliquis (apixaban) over warfarin in the atrial fibrillation population was thought to set the Factor Xa inhibitor apart from the two other novel oral anticoagulants recently approved by FDA. In the end, however, the mortality data and its presentation were not all that different from Boehringer Ingelheim GMBH’s direct thrombin inhibitor Pradaxa (dabigatran).

While the apixaban mortality findings in ARISTOTLE were statistically significant, they just barely met this threshold. In review documents, agency staff used such words as “marginal” and “fragile” to describe...

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More from United States

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

GLP-1 Pricing ‘Paradigm Shift’ Possible, But Would It Meet Trump’s MFN Goals?

 
• By Cathy Kelly

For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

More from North America

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.