Amgen’s Evolocumab At FDA: Dawn Of PCSK9 Era Still Cloudy
This article was originally published in Pharmaceutical Approvals Monthly
Firm files BLA for eagerly-awaited PCSK9 inhibitor for high cholesterol, amid continued uncertainty on surrogate markers in cardiovascular trials; Amgen’s heart failure drug ivabradine now has priority review status from FDA and could help pave the way for evolocumab.
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Companies’ decision to purchase and redeem BioMarin’s priority review voucher for their PCSK9 inhibitor alirocumab sets the first public benchmark for a voucher’s value and shows the potential advantages to be gained for sponsors in a race to market.
The strong efficacy and sound safety data coming out of the Phase III programs presented at ACC have all eyes on the commercial opportunity for the PCSK9 inhibitor class. Ongoing outcomes trials and market impact of new cholesterol guidelines sparked discussion, and leading sponsors Amgen and Sanofi/Regeneron talked about the potential populations and differences in the devices and dosing of evolocumab and alirocumab.
The cardiology community is increasingly questioning the value of adding on a variety of lipid therapies to treatment with highly effective statins, based on accumulating evidence of the lack of value of affecting cholesterol parameters other than LDL.