Drugs that lower cholesterol dramatically will approve, practical application will be expected but there are remaining concerns

ByRakka

"Cholesterol" which you often hear in the results of medical examinations etc. should be anxious name, especially if it is between adult men and women. Among them, "bad cholesterol" also called "LDL cholesterol"Cause heart disease, etc. arising from arteriosclerosis, sometimes risking life can be dangerous, so many people are happy with a change in their values.

In order to lower the cholesterol levelStatin systemAlthough drugs are often used, new drugs that can dramatically lower the cholesterol level more dramatically than these existing drugs have become the trend of getting approval from the Food Safety Administration (FDA) of the United States. For people suffering from symptoms it is a new medicine with great expectations, but there seems to be situations where it is not easy to do.

FDA Panel Backs Cholesterol Drug, but Raises Concerns - WSJ
http://www.wsj.com/articles/fda-panel-backs-cholesterol-drug-but-raises-concerns-1433884972

Federal Panel Backs Approval of New Drug to Fight Heart Attacks - NYTimes.com
http://www.nytimes.com/2015/06/10/health/cholesterol-levels-ldl-drugs-heart-attacks-fda-panel.html

Statin medicines are widely used all over the world as a drug that lowers cholesterol level, and the market size of the whole world is the largest2 trillion yenIt is also said. On the other hand, the existence of side effectsVoiced doubtful effectStatins had problems such as.

At the internal committee of the US Food and Drug Administration (FDA) held on 9th and 10th June 2015, a new drug "Alirocumab"(Product name Praluent) and"Evolocumab(Product name: Repatha) was discussed and voted. First, we got a result that approval was recommended with 13 votes in favor of alirocumab and three votes opposing. In addition, the same deliberations will be held for evolocumab as well. Normally, the conclusion reached at the committee is directly reflected in FDA approval, so it seems that the practical application of new drugs is almost certainly in a state that can be said.

ByEpSos .de

The alirocumab that I got on this agenda is Sanofi (France) and Regeneron Pharmaceuticals (USA), while one evolocumab was developed by Amgen (USA), and "PCSK9 inhibitorIt is said to be a medicine using an unconventional mechanism called " PCSK9 is one of the enzymes present in the liver, which has the function of preventing the liver from removing bad cholesterol from the blood, but the new drug prevents accumulation of bad cholesterol by lowering this effect It is expected to lower the cholesterol level in the blood and lower the risk of heart disease and the mortality caused by it.

For both patients, injections to be administered using injections for patients, the evaluation test over 24 weeks conducted on actual patients showed that the value of bad cholesterol in this group was about 40% To 60%, and it becomes the evaluation targetPlacebo groupIt has been confirmed that it was clearly lower than that of the other. This decision is based on the fact that the FDA's committee recognized the influence of each new medicine on cholesterol level and if it is not possible to demonstrate the effect of reducing the risk of heart attack and death in ongoing clinical trials However, we say that this approval will not be canceled.

Following this decision, sanofi's share price has reached $ 50.92 cents, showing a 3% rise on overtime markets. Joshua W. Knowles, a cardiologist at Stanford University, evaluates the drug as "a feat in modern genetic revolution".

BySanofi Pasteur

On the other hand, however, it is also true that the new drugs are saying that "the number of clinical cases is still too small" against the effect of statin drugs that have been proven for 20 years, also from the committee members. In addition, many members pointed out that the effect on bad cholesterol is "there are concerns that different effects may occur due to differences in patient groups".

There are also concerns about which phases of patients to include in the use of new drugs. The cost of using new medicines is estimated to be 1000 dollars per patient per month (about 120,000 yen), but if the patient who is the subject of a new drug is dangerously high in cholesterol level and statin medicine If you limit to a layer that you can not expect the effect of, the cost required for one year in the United States is estimated at $ 16 billion (about 2 trillion yen).

Even if only 2 trillion yen is equivalent to conventional statin medicine, it will be the same amount or even more than it. However, if you add a patient who is not in a crisis situation and who is not able to take medicine without matching the statin medicine, The cost of 20 billion dollars (about 2.5 trillion yen) will be added. In addition, if you also include patients who have suffered from heart disease, the additional cost of borrowing a huge medical expenses of 150 billion dollars (about 19 trillion yen) will be born , Medical expenses for new medicines are expected to step into areas that have never been experienced in the past.

ByImages Money

Cost raised raises concern about the situation that drugs are not distributed to patients who really need new drugs. Halean M. Kulmholz, a cardiologist at Yale University, has revealed the fact that pharmaceutical companies have already begun sales to promote the use of new drugs to doctors throughout the country, and " People who can not use it because they do not fit at all and people who can not use it will have a certain percentage but there is a certain percentage of new drugs for such patients ___ ___ 0 It is a medicine to be able to do, so for those who really need it, such a new medicine should be prepared. "

Both sanofi and regeneron talk about the prospect of starting marketing of new drugs in 2017 as well.