Trump Could Soften FDA Standards - Diverse Health

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Trump Could Soften FDA Standards


by By John LaMattina, Contributor

They were hailed as drugs that could change the treatment of heart disease by lowering harmful LDL cholesterol (LDL-c) to unprecedented levels for adults. Yet, the sales of Amgen’s Repatha and Sanofi/Regeneron’s Praluent, known as PCSK9 inhibitors, have been disappointing low. The reason isn’t due to lack of efficacy. Indeed, combining PCSK9 inhibitors with generic statins can drop LDL-c to below 40mg/dL, almost the levels of newborns, with no major safety issues. What has limited the uptake of these drugs has been the price–listed at $14,000 a year. As a result, payers have made access difficult, requiring extensive documentation showing that patients are truly in need of such potent therapy. In fact, 88% of first-time prescriptions for patients with commercial insurance were denied access last year.

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