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Broad Enough? Sponsors Pleased With Narrower Praluent Label

 
• By Sue Sutter

Indication for cholesterol-lowering drug is narrower than Sanofi and Regeneron originally sought, but firms still see it as broad. Target patient population is estimated at 8-10 million patients, but sponsors are quick to say the number of actual users will be funneled down.

FDA approved Sanofi and Regeneron Pharmaceuticals Inc.'s Praluent (alirocumab), the first PCSK9 inhibitor in the U.S., July 24 with what the sponsors view as a broad label, though one that is narrower than requested in the U.S. and likely to be approved in Europe.

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More from United States

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• By Bridget Silverman

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US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
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• By Cathy Kelly

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Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.

More from North America

US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 
• By Bridget Silverman

All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote

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• By Cathy Kelly

Wide-ranging executive order to lower drug prices also hints at changes in upcoming guidance on the Medicare price negotiation program but few other potentially impactful near-term actions.

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.