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Old Mon, Jun-08-15, 08:14
JEY100's Avatar
JEY100 JEY100 is offline
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Plan: P:E/DDF
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Default FDA Reviews of New Cholesterol lowering drugs

Since this is the Wall Street Journal, no surprise that this story is positively gleeful about new drugs in the pipeline and that a month's supply will cost $1000! and be a $10 Billion blockbuster! What is notable that already 39 comments, many pointing to the side effects of statins and the futility of lowering LDL to actually Reduce CVD.

http://www.wsj.com/articles/fda-que...rugs-1433583182

Quote:
A Food and Drug Administration advisory panel this week considers experimental cholesterol-lowering drugs whose approval could pave the way for blockbuster medicines with potentially billions of dollars in sales.

The panel is evaluating evolocumab from Amgen Inc. and alirocumab from Sanofi SA and partner Regeneron Pharmaceuticals Inc., new LDL-lowering agents that would be the first major additions to the coronary heart-disease medicine chest since statin pills were first prescribed in the late 1980s.

“This is the next big quantum leap in being able to control cholesterol and potentially reduce the risk of” heart attacks and strokes, said Bill Sasiela, who heads the cardiovascular and metabolic program at Regeneron.

Statins, such as Lipitor from Pfizer Inc. and Crestor from AstraZeneca PLC, will remain a backbone of efforts to lower “bad” LDL cholesterol and reduce the risk of heart attacks and strokes. Yet doctors have been looking for another option because millions of people with high cholesterol can’t tolerate statins or get their condition under control using the drugs.


[Really? Now doctors and drug companies admit this??]

Quote:
The new biotech drugs block a protein called PCSK9, which interferes with the liver’s ability to clear bad cholesterol. Both are injections that drug companies say patients will be able to give to themselves at home. Studies indicate their use dramatically lowers bad cholesterol levels in patients, and the companies say studies have shown the drugs to be safe.

One concern, which the FDA has discussed with companies, is whether use of the drugs could raise the risk for side effects such as memory impairment or delirium. The companies say they continue to study the matter, but that so far, testing doesn’t suggest a heightened and significant risk.

Also unclear is whether the cholesterol reductions seen in patients taking the new agents also reduces their risk of heart attacks and strokes, though the FDA typically accepts that sizable reductions in bad cholesterol translate into cutting the cardiovascular risks. Company-sponsored “outcomes” studies probing the issue are under way and expected to finish in 2017 or earlier.

Given the potential size of the market, the PCSK9 class could be among the industry’s biggest-selling new classes. Sales could reach as much as $10 billion a year world-wide, estimate analysts at brokerage firm Goldman Sachs Group Inc.

But the drug companies could face a fight from health plans and drug-benefit managers. The price of the drugs could approach $1,000 a month, according to analysts at Sanford C. Bernstein & Co. That could means billions of dollars in additional drug-reimbursement costs for payers, who have already begun making noises about taking steps to limit use.

“Managed pharmacy care, indeed the health care system, has never seen a challenge like this to our resilience in absorbing costs,” CVS Health Corp. executives wrote last February on the blog of the journal Health Affairs. “Action will take the form of compliance with clinical guidelines, and careful managed care oversight.”

The drug companies wouldn’t discuss their pricing plans, but touted the public-health benefits of preventing heart attacks and strokes. Helping patients achieve healthy cholesterol levels “will provide significant medical value,” said Jay Edelberg, who heads PCSK9 development at Sanofi.

“If approved, Repatha would provide patients and physicians with an important new treatment option for managing high cholesterol,” Sean E. Harper, Amgen’s research and development chief, said in a statement.

Drug companies have been angling for any competitive advantage with the new drugs. Sanofi and Regeneron got first dibs on FDA approval by paying $67.5 million for a voucher that moved up their decision date to late July, about a month ahead of the deadline for Amgen’s drug. The FDA isn’t bound by the recommendations of its advisory committees but usually follows them.

Last October, Amgen filed a patent suit against Sanofi and Regeneron asking a federal court to prevent sales of their drug. Sanofi and Regeneron say Amgen’s lawsuit lacks merit.

The companies also have been trying to make the case that the dosing regimen for their drug is superior to their rivals’. The companies have been using the brand names for their drugs, which they often don’t do until FDA approval. Amgen’s drug will be called Repatha, while Sanofi and Regeneron call theirs Praluent.

The prospects for PCSK9 sales are bright enough that Pfizer has been racing to catch up and be part of the conversation about the drugs. “Given the size and diversity of patients, we think there is an opportunity to be competitive,” said Geno Germano, who heads the Pfizer business that is developing a PCSK9 injection, pill and vaccine.

Last edited by JEY100 : Mon, Jun-08-15 at 09:24.
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