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Xarelto Expanded Indication May Depend On Containing Worries About Bleeding

 
• By Martin Berman-Gorvine

FDA advisory committee will review J&J/Bayer’s anticoagulant for a claim of reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome. The product has a profoundly stronger database, but the same set of safety concerns, compared to when it was initially approved.

In considering a supplemental indication for Johnson & Johnson and Bayer AG’s anticoagulant Xarelto (rivaroxaban) on May 23, FDA’s Cardiovascular and Renal Drugs Advisory Committee might feel a bit of déjà vu, as bleeding events pose a safety concern just as they did when the panel took up the initial indication three years ago. But this time, the clinical database is more than twice as large and points to a statistically significant survival benefit.

The new application, for reducing the risk of thrombotic cardiovascular events in patients with ACS (ST or non-ST elevation myocardial infarction or unstable angina) in combination with aspirin alone or...

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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.