PCSK9 and statins: next stages will be crucial

Monoclonal antibodies Praluent (alirocumab, Sanofi and Regeneron) and Repatha (evolocumab, Amgen), target PCSK9 to lower LDL.

The new injectable drug, known for now as ALN-PCSsc, uses RNA interference technology to inhibit the synthesis of PCSK9 in the liver. The drug was created by Alnylam Pharmaceuticals and is now being developed by the Medicines Company.

"Of course the future of the drug, along with all other PCSK9-related drugs and other novel LDL drugs, depends heavily on the results of the very large cardiovascular outcomes trial now underway with the PCSK9 inhibitors.

Speaking about the overall direction of the cholesterol market, Meanwell said that industry needs to show that expensive new drugs confer tangible value.


"We don't know what you save if you avoid a heart attack. We're going to have to be creative," he said, adding that this may involve innovative models of payment that could involve "risk sharing."

Meanwell said that some wild predictions about the cholesterol market are unrealistic. "That's not going to happen," said Meanwell, referring to a $150 billion nightmare scenario in which 10 million eligible patients receive PCSK9 inhibitors at a yearly cost of $15,000.

Meanwell also speculated about a "phase V" study testing a strategy using the new drug to replace statins."

http://www.medpagetoday.com/Cardiology/Dyslipidemia/53319?xid=nl_mpt_DHE_2015-08-31&eun=g432148d0r

You can look at the numbers and they are impressive:
http://investors.alnylam.com/releasedetail.cfm?ReleaseID=929318