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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.

Praluent is indicated for patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who are taking maximally tolerated doses of statins

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More from United States

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• By Sarah Karlin-Smith

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• By Sue Sutter

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• By Ramsey Baghdadi

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US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.

More from North America

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

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House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

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Trump’s Rx Pricing Order: The Best-Case And Worst-Case Scenarios

 
• By Derrick Gingery

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