(CNN) A Food and Drug Administration advisory committee this week recommended approval of two experimental new cholesterol-fighting drugs that could be more potent and carry fewer side effects than statins, which are among the most prescribed drugs in the United States. 
 
 The agency will likely follow the advisory committee's advice when it decides whether to approve the drugs, alirocumab (Praluent) from Sanofi SA and Regeneron Pharmaceuticals Inc., and evolocumab (Repatha) from Amgen Inc., for patients later this summer. 
 
 The drugs represent the most important new class of cholesterol-lowering medications since the first statin was approved in 1987. Seven statins are available in the United States, including Zocor, Lipitor and Crestor. 
 
 The new drugs are a "powerful new way of lowering the bad form of cholesterol, and that has profound implications in dealing with the burden of vascular disease," which can lead to heart attacks and stroke, said Dr. Elliott Antman, president of the American Heart Association. 
 
 Although statins will continue to be a mainstay for the management of high levels of bad (LDL) cholesterol and reducing risk of heart attack and stroke, Antman said there are two groups of patients who could strongly benefit from having an alternative to statins. 
 
 One is the group that experiences severe side effects to statins, and as a result may stop taking them. The most common side effect is muscle pain and weakness, which is estimated to affect between 10% and 25% of users. In contrast, clinical trials of alirocumab and evolocumab did not find an increase in muscle pain among study participants taking these drugs for several months compared with those taking a placebo control. 
 
 The other group is people whose levels of LDL cholesterol still hover above the desirable range even after taking statins. Although a small subset of this group — about 1 in 500 of all people with high cholesterol — have a genetic predisposition (familial hypercholesterolemia) that could affect their response to statins, it is not clear why others do not get sufficient cholesterol-lowering benefit, Antman said. 
 
 "There is a tremendous unmet need" beyond statins, said Dr. Robert S. Rosenson, director of the Cardiometabolics Unit at the Icahn School of Medicine at Mount Sinai. 
 
 Patients who cannot tolerate, or do not respond adequately to, statins can take other medications but they are generally expensive and may not be that effective at reducing cholesterol, said Rosenson, who has been involved in trials of evolocumab and is on the international Data and Safety Monitoring Board for Sanofi-Regeneron Pharmaceuticals (which is sponsoring alirocumab). 
 
 In a study of nearly 4,500 patients, including those who did not tolerate or respond to statins, 90% of patients who took evolocumab along with standard therapy had LDL levels in the optimal range after three months, compared with 26% in the group that took the standard therapy alone (which depending on the care center could include medications and exercise and diet regimens). 
 
 In this study, the rates of heart attacks, strokes and other cardiovascular disease were also lower (1%) in the evolocumab group compared with the standard therapy (2.2%). So far, clinical studies of alirocumab suggest it is similar in effectiveness to evolocumab. "Preliminarily, there appears to be no striking difference between the two," Antman said. 
 
 Although there has been some concern that the dramatic drop in LDL levels achieved with these drugs could actually be harmful, the concern has not panned out. "That is of course something that everybody has been watching, and I have been pleased with what I have seen to date," Antman said. He added that alirocumab and evolocumab may lower LDL down to between 30 and 40 milligrams/deciliter. (The optimal range is below 100 milligrams/deciliter.) 
 
 The potency of these drugs comes from the fact that they block a protein in the body called PCSK9, and are thus called PCSK9 inhibitors. The result of this inhibition is that more molecules known as LDL receptors are available on the surface of cells in the liver to take up LDL, clearing this bad form of cholesterol from the body. 
 
 There have also been concerns that alirocumab and evolocumab, like statins, may induce short-term memory loss. The FDA warned statin users about this possibility in 2012. 
 
 However, a study published on Monday made a strong case that statins are not responsible for short-term memory loss, and instead that patients are simply more likely to notice mental shortcomings after they start any new medication, statin or otherwise. Likewise, Antman said it is "very unlikely" that alirocumab and evolocumab could precipitate forgetfulness. 
 
 If the new drugs are approved, it is estimated they would cost between $7,000 and $12,000 a year per patient. In comparison, statins cost between $48 a year (for generic forms), up to between $500 and $7,000 a year (for brand-name drugs). 
 
 However, "if we [balance] the cost of these drugs over society and the cost to our health care system for caring for patients who suffer the consequences of vascular disease," Antman said, "it's possible that the calculus would suggest this could be a cost effective and attractive approach." 
 
 One downside to alirocumab and evolocumab is that they have to be injected, which could be more cumbersome for patients than taking a statin, which is a pill. "That was our initial concern [but] it's pretty easy and well tolerated by our patients," Rosenson said. Patients take an injection, via a device similar to the FlexPen for diabetes, once or twice a month. 
 
 Although PCSK9 inhibitors would at first probably be used primarily by patients who have bad reactions or do not respond to statins, these drugs could down the road be used more broadly in people with high cholesterol, Antman said. "If we were able to reduce the LDL levels in our population to ranges we have not seen before [because of the potency of these drugs], could we reduce the burden of vascular disease in our population and the economic cost to our society?" 

 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. 
 
 FILE - This Nov. 9, 2014 file photo shows signage at the entrance to Amgen Inc. offices in Thousand Oaks, Calif. Federal health advisers on Wednesday, June 10, 2015 said that a highly-anticipated cholesterol-lowering... (Associated Press) 
 
 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. 

 Once a drug is approved doctors can prescribe it to patients other than those for whom it was intended, although insurers generally will not pay. 
 
 The drugs are injected every two weeks or once a month, depending on the formulation. The companies are asking that they be approved for use in three groups: patients with high levels of LDL cholesterol who cannot lower it enough with statins, the mainstay drug for cholesterol lowering first introduced in the late 1980s; people at very high risk because they have already had a heart attack or have diabetes and cannot get their levels low enough with statins; and people with high levels of LDL who cannot tolerate statins. Doctors often aim for LDL levels of 70 for people at high risk. 
 
 The problem for the expert group was to decide if there was enough evidence to approve the Sanofi drug without waiting for results from the large clinical trials. Those who voted no said drugs should not be approved until clinical trials established their efficacy, and voiced the worry that people participating in the trials would drop out once the drugs were approved so they could be sure to get the medicine, not a placebo. 
 
 “We need clinical outcomes,” said Dr. Peter Wilson of Emory University. 
 
 Some on the panel felt comfortable recommending approval only for a narrow group of people with a genetic condition, heterozygousfamilial hypercholesterolemia, who cannot control their cholesterol with statins alone. Others favored allowing use of the drug by the much larger group of people at high risk of heart disease for whom statins are insufficient. 
 
 The group’s chairman, Dr. Robert J. Smith of Brown University, argued for broader availability of the drugs. He said he sees patients in his own practice with out-of-control cholesterol who are at very high risk because, for example, they have already had a heart attack. Two years is a long time for them to wait for clinical trial findings. “I am unwilling to subject patients to that wait,” Dr. Smith said. 
 
 The companies and many independent cardiologists say they have reason to believe the drugs will perform as expected. Lowering LDL cholesterol has generally been found to protect against heart disease. And, they say, the drugs were designed to mimic mutations in a gene, PCSK9, that protects people from getting heart disease, even if they smoke or have high blood pressure. 
 
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 But the drugs have caused trepidation among insurers and others who would have to pay the bills because the drugs are certain to be expensive — perhaps $10,000 a year — and millions of people are likely to qualify to take them if they are approved for the broader group. Sanofi estimates that 11 million Americans might qualify. Amgen puts the number at eight million. 
 
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 So far, it looks as if just about everyone who takes the new drugs responds. LDL cholesterol levels plunge by 40 to 65 percent, even if the starting level was achieved with a statin. 
 
 Safety studies so far have found the drugs seem to have no more side effects than a placebo, but the large clinical trials are needed to get more substantial information. 
 
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 Meanwhile, pharmaceutical companies see the tantalizing prospect of multibillion-dollar blockbuster drugs, and are racing to get them to market as rapidly as possible. Sanofi bought an F.D.A.-backed voucher for $67.5 million that gave them an expedited review. The company says the F.D.A. agreed to decide whether to approve its drug by July 24. Amgen, which did not pay, expects an answer by Aug. 27, the company says. Pfizer also has a drug in this new class, but it is further behind in development. 
 
 The powerful effect of the gene, PCSK9, that the drugs block was discovered when researchers found people who were born with one copy mutated so it did not function. They seemed to be protected against heart disease. Then researchers found two young women with both copies knocked out. Both had astonishingly low cholesterol — 14 for one and 15 for the other. That indicated that it might be safe to block the action of the gene with a drug and drive LDL levels very low. 
 
 But people with the gene mutations had lower cholesterol levels their entire lives. With cholesterol-lowering drugs, most people start treatment in middle age, after heart disease is established. Would it be better to start much earlier in someone with high LDL? How low should LDL go? 
 
 The evidence so far says that lower is better and that there is no known point at which the increasing benefits of dropping LDL levels even out. Some people in the clinical trials, in fact, have gotten their LDL levels as low as 15. Is that good? A bit nervous about very low levels, Sanofi decreases the drug dose when LDL falls below 25. 
 
 Then there is the question of cost. The new drugs, like many new cancer drugs, are monoclonal antibodies, produced from living cells at great expense. The companies will not say what they plan to charge. But Dr. William Shrank, chief scientific officer at CVS Health, estimates they will cost $7,000 to $12,000 a year. 
 
 If drugs were restricted to people with dangerously high cholesterol levels who cannot get their LDL low enough with statins, the cost would be $16 billion, he estimated. If people who are intolerant to statins are included, that would add another $20 billion. If people with a history of heart disease are included, the bill for the drugs rises another $150 billion. 
 
 “Managed pharmacy care, indeed the health care system, has never seen a challenge like this to our resilience in absorbing costs,” Dr. Shrank wrote in Health Affairs. 
 
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 Dr. Harlan M. Krumholz, a Yale cardiologist, worries that the patient population who take the drugs will expand beyond limited categories. Already, he said, the companies are conducting aggressive education campaigns and slipping brochures under doctors’ doors at medical meetings. 
 
 “We need to watch this carefully,” he said. “These drugs should be reserved for people who have no choice.” 
 
 “There are some people, a relatively small group, who are at very elevated risk because they don’t tolerate statins or because statins don’t have enough of an effect,” he said. “This is a way for patients to make a choice, to know the final evidence is not in but to decide they are willing to try these drugs.”
– A new batch of cholesterol-lowering drugs could bring new hope to patients who can't take popular statins, or for those who don't feel their effects. Today, an FDA advisory committee recommended approval of Amgen's Repatha, reports AP, just one day after it gave the green light to a similar drug called Praluent from Sanofi and Regeneron. Both self-injected drugs are designed to lower LDL cholesterol (the "bad cholesterol") and belong to a class of drugs known as PCSK9 inhibitors, HealthDay reports. Early studies suggest they lower LDL more effectively than statins. The FDA will make its decision this summer, but is expected to follow the committee's advice, reports CNN, which calls the drugs "the most important new class of cholesterol-lowering medications since the first statin was approved in 1987." However, "definitive evidence" on whether they actually reduce heart attacks and deaths won't be out until 2017, after long-term trials, reports the New York Times. While statins are proven to prevent heart attack and stroke, they don't work for everyone, and up to 25% of statin users battle side effects like muscle pain, which hasn't appeared in trials of PCSK9 inhibitors, notes CNN. However, some patients on PCSK9 inhibitors have reported being confused and unable to focus. "For all those patients unable to take statins, finally there might be an option that can change (their) outcomes," says a cardiologist not involved in the research. "We need to patiently wait for the next phase of trials to see whether the clinical outcomes are as promising as the initial studies suggest." The downside: Most estimates say the drugs could cost $10,000 per year, while statins cost a few hundred dollars per year.