Does Esperion's Plan For A Statin-Intolerant Claim Have A Shot?
Esperion says it is working with FDA to forge a new regulatory path for its cholesterol drug ETC-1002 in statin-intolerant patients – a population the agency has been very cautious about in the past.
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Esperion Says FDA On Board With Filing Strategy For Bempedoic Acid
Unlike Amgen's FOURIER study of Repatha, which disappointed investors with a lower magnitude of benefit than expected, Esperion's outcomes trial of bempedoic acid will be done in patients with higher baseline LDL and will be much longer.
FDA’s Zetia/Vytorin Rejection Leaves Cholesterol Drug Sponsors In Limbo
FDA’s complete response letter for the cardiovascular risk reduction claim for Zetia/Vytorin was expected, but what will this mean for sponsors of drugs with other mechanisms, like PCSK9?
Amgen Racks Up Positive Phase III Data For Blincyto And Repatha
Company announces positive results from a confirmatory study of bispecific antibody Blincyto, on the heels of unveiling positive new data for PCSK9 inhibitor Repatha in statin-intolerant patients.