Praluent Sponsors Set Tone For PCSK9 Labeling, Post-Marketing Negotiations
Sanofi and Regeneron's 'extended negotiations' with FDA on requirements would later apply to Amgen's Repatha.
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PCSK9 Inhibitor Labeling Parity Is Within Reach As Praluent And Repatha Strive To Make Commercial Case
Sanofi and Regeneron’s Praluent could draw even with Amgen’s US Repatha in approved FDA indications in 2019. While the injectable PCSK9 inhibitors battle for payers and prescribers, Esperion is readying its oral bempedoic acid to join the lipid-lowering fray – and strategizing towards what could be the first statin intolerance indication.
Amgen's FOURIER outcomes study of Repatha supports LDL-lowering in high risk patients, but price may have to come down dramatically to spur wide use of the PCSK9 inhibitors with the subjective condition of statin intolerance.
A listing of the Drug Review Profile series articles published in the Pink Sheet.