Positive Phase III Clinical Results for Amgen’s PCSK9 Inhibitor

>Amgen yesterday announced further positive clinical data for their novel cholesterol buster, evolocumab, putting it ahead in the race to get the first PCSK9 inhibitor to market.

The Phase III clinical trial of evolocumab, an injectable monoclonal antibody that inhibits PCSK9 (proprotein convertase subtilisin kexin type 9), met the primary endpoint of percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C).

The clinical study assessed the safety, tolerability and efficacy of evolocumab compared to placebo in 49 adults and adolescents (between 12 and 18 years old) with homozygous familial hypercholesterolemia who were on a stable dose of statin therapy and other lipid-lowering medication.

Sean Harper, executive vice president of Research and Development at Amgen noted that “homozygous familial hypercholesterolemia is a rare and devastating disease characterized by extremely high LDL-C levels that increase cardiovascular risk in these patients, many of whom are affected at an early age.”

Up to 80% of high risk patients are not currently reaching their cholesterol treatment goals using statin therapy, emphasising the requirement for new therapies, and analysts believe that the PCSK9 inhibitors could earn sales of approximately $3-$4 billion each.

Specific data from the clinical trial has not yet been released, but Harper commented the company is “encouraged” by the results, adding that the trial suggests that “evolocumab may offer a new treatment option for these patients who currently have significant unmet medical needs.”

The risk of adverse events was generally balanced between patients taking evolocumab alongside statins and those just taking statins, with the most common adverse events of the PCSK9 inhibitor including upper respiratory tract infection and gastrointestinal inflammation.

Amgen is not the only drugmaker trying to enter this highly lucrative market.  Both Pfizer’s RN-316 and Sanofi/Regenron’s alirocumab are also currently trying to become the first PCSK9 inhibitor in the market.


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