Amgen submits next gen cholesterol drug
pharmafile | August 29, 2014 | News story | Sales and Marketing | Amgen, FDA, PCSK9, Regeneron, Sanofi, statins
Amgen has put itself in pole position in the race to market the next generation of injectable statins known as PCSK9 inhibitor, after submitting evolocumab to the FDA.
This makes the US biotech giant the first to seek approval of a medicine from a closely-watched new class of heart drugs.
It is currently battling against Regeneron and partner Sanofi to bring to market the potentially lucrative new drugs aimed at patients unable to tolerate widely used statins, or cannot lower cholesterol because of a genetic condition.
Pfizer, creator of the world’s biggest-selling statin Lipitor (atorvastatin) before it began losing patents in 2012, is also developing a PCSK9 inhibitor but is behind Amgen and Regeneron in terms of clinical development.
Analysts expect the new class of drugs, including those in earlier stages of development at Merck and Bristol-Myers Squibb, to generate annual future sales of up to $20 billion.
In the latest series of late-stage clinical trials, evolocumab cut LDL levels by more than 50%, even in patients already taking other cholesterol medicines.
The injectable drugs work by blocking a naturally occurring protein called PCSK9 that prevents the liver from removing LDL cholesterol from the bloodstream.
“This BLA submission to the FDA marks the first of several submissions to regulatory authorities around the world for our lipid-lowering program and represents a critical milestone in our overall global development program for evolocumab,” says Sean Harper, executive VP of Research and Development at Amgen.
“We look forward to working closely with regulatory authorities to bring this new treatment option to patients with high cholesterol who, despite currently available therapies, are unable to adequately reduce their LDL cholesterol levels.”
Ben Adams
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