US: FDA panel backs Amgen cholesterol drug for some patients

[webfact]

FDA panel backs Amgen cholesterol drug for some patients
MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — Federal health advisers said Wednesday that a highly-anticipated cholesterol-lowering drug from Amgen Inc. should be approved for patients with dangerously high levels of the artery-clogging substance.

But as with their review of a similar drug a day earlier, the Food and Drug Administration experts stressed that long-term results are needed to judge the drug's real benefit.

The FDA advisory panel voted that Amgen's injectable drug Repatha appears safe and effective for some patients at high-risk from cholesterol, particularly those with inherited conditions that cause cholesterol buildup. The FDA is not required to follow the group's advice, though it often does.

The endorsement came despite pending study results on whether Repatha ultimately lowers rates of heart attack and death. Results from an Amgen study on that question aren't expected until 2017.

Repatha is part of a new class of biotech drugs that lower cholesterol more than older statin medications, which have been the standard treatment for more than 20 years.

Amgen is racing rivals Sanofi and Regeneron Pharmaceuticals, who received a positive vote on Tuesday for their own drug, Praluent.

An approval decision on Amgen's drug is due by Aug. 27, about a month after Sanofi and Regeneron's July 24 target date.

Both drugs lower low-density lipoprotein, or LDL, cholesterol more powerfully and in a different way than statins. They block a substance called PCSK9, which interferes with the liver's ability to remove cholesterol from the blood. Adding the new drugs to older statins has been shown to reduce LDL, or "bad," cholesterol, by 40 percent to 60 percent. Statins alone generally lower levels of the wax-like substance by about 30 to 50 percent.

GlobalData, a medical analytics company group, expects the PCSK9 class to generate sales of nearly $18 billion by 2023, based on sales projections for major pharmaceutical markets.

But the prospect of approving a pricey new class of drugs for one of the most common medical conditions in America is already drawing concerns from health insurers, employers and other payers who would absorb the costs. None of the companies developing the products have discussed their plans for pricing. But some industry analysts estimate new PCSK9 drugs could cost $10,000 or more per year, compared with just a few hundred dollars per year for currently-used statin drugs.

More than 73 million U.S. adults, or nearly one-third, have high LDL cholesterol, according to the Centers for Disease Control and Prevention. Those patients have twice the risk of heart disease, the leading cause of death in the U.S. Panelists made clear this week that the new drugs should only be used for patients who cannot manage their condition with statins.

How doctors prescribe the drugs will be heavily influenced by the prescribing label written by the FDA. The agency will consider its advisers' recommendations as it crafts that language.

Amgen said in a statement the panel results show "there is a critical need for additional treatment options for patients who are unable to control their high cholesterol despite currently available therapies." Repatha is designed to be self-injected by the patient every two or four weeks, depending on the dose.

Shares of Thousand Oaks, California-based Amgen rose 1 percent to $157.20 in afterhours trading Wednesday. Shares of Regeneron Pharmaceuticals Inc., which is based in Tarrytown, New York, fell $13.77, or 2.6 percent, to close at $512.32 in regular trading. Paris-based Sanofi rose $1.17, or 2.4 percent, to $40.60 in regular trading.

-- (c) Associated Press 2015-06-11

[ezzra]

Wait for about 10 years for the US patent to expire and you can have them for next to nothing,

and the way things are going, there will be still many millions of people in need for this kind

of medicine....

[NeverSure]

"Now, patents protect drugs from copycat versions for 20 years after the drug is invented. This is a bitter pill for pharmaceutical companies because

it can take eight years or more after invention to accumulate enough data to get a drug past the U.S. Food and Drug Administration." Forbes

In layman's terms, the patent is good for just 20 years after the discovery, but it can take roughly another 10 years to bring it to market with FDA approval. There are all of the trials and testing and even lawsuits from people wanting a piece of the pie. The short version is that the developer may have less than ten years to recover the investment and make a profit after which every Tom, Dick and Harry in the world can sell the generic.

The result is less and less effort being made to develop new drugs because it's not only expensive but risky in that nothing may come of it.

Some other inventors and producers of new products such as music, artwork and literature get to own it and its income for life and they can even leave it in their estates.

Edited June 11, 2015 by NeverSure

[BlackJack]

there are plenty of natural ways to lower cholesterol

plenty