The U.S. regulatory authority for drugs ( Food and Drug Administration , FDA) has yet again a new diet pill denied marketing approval, and thus an entire industry shock offset. It will probably come after that sentence for a long time to no new diet pill in the U.S. anymore.
This has sent the agency a clear signal to industry that they extremely careful when evaluating new weight loss products is, when some older products that are no longer on the market, serious side effects have shown .
Contrave is the third product, the FDA has denied marketing approval in recent months.
After Orexigen on Tuesday the decision of the FDA has announced have to several experts and patient groups critical spoken up and warned that the procedures and requirements of the FDA any further attempt, a new diet pill on the market could inhibit or even prevent completely.
"The FDA has done no favors with this decision, she has decided that, that the currently most important health problem no medical treatment will be made available, "writes Morgan Downey, editor of the online Downey Obesity Report . "With the current design of the safety aspects not even tap water would be approved by the FDA."
The FDA's decision was not entirely unexpected. Contrave has been shown in clinical studies only a slight effect on weight loss . The amazing thing is the decision by the FDA rather that it has established for the first time admission to the condition that the means risk for heart cardiovascular problems a large study should be investigated. Large-scale studies
in heart and circulation area can easily go for several years and in the worst case cost hundreds of millions - death sentences for many drugs in the experimental stage. The leaders of Orexigen have not yet expressed themselves to be authentic. They obviously are looking to talk to leaders of the FDA to study the conditions of such to define precisely. But they made clear in a first reaction to the decision, now that all options were being considered to provide also that the drug in the drawer.
"This is clearly the worst-case scenario for Orexigen," said a prominent Wall Street analyst. The stock lost 72.5 percent as well as dramatic readings of their previous day. Not only does this verdict, for Orexigen a big loss. Also Takeda Pharmaceutical , a Japanese pharmaceutical manufacturer that had the American distribution rights for Orexigen initial $ 50,000,000 is secured, now with empty hands. Analysts said as well that could mean an end to cooperation with Orexigen, Takeda.
After Contrave now for the next few years will hardly appear on the American market, is Xenical from Roche, the last weight-loss drug that was approved in 1999 by the FDA. A drug that notabene in recent years lost rapidly in sales and popularity and has applied as the sole option for weight hardly. The last two drugs, a similar fate as that suffered by Contrave have were lorcaserin the company Arena Pharmaceuticals and Qnexa of Vivus. In addition, the FDA, the company Abbott Laboratories practically forced sibutramine (Reductil) to voluntarily from the market.
For Contrave saw matters not that bad at first from. In general, it was assumed that the FDA would basically give their consent for the new product - may be associated with shorter runs, which would have delayed the launch by only a few months. Having had such hopes on a decision of the advisory panel last December, which had expressly stated in a 13 to 7 vote for the introduction of Contrave .
Although the advisory committee had also requested that this must be better investigated risk for heart cardiovascular disease, but agreed in a ratio of 11 to 8 for that this evidence can be provided after the launch.
"We are surprised and extremely disappointed about the requirements of the FDA in light of the detailed discussion of this topic within the advisory commission, which has a yes in the vote of 7 December last year, reflecting, "said Michael A. Narachi, CEO of Orexigen in a statement.
Contrave is a combination product of two already approved drugs to help keep together the joy of eating or suppress. One of the components Bupropion is an antidepressant and as Zyban in smoking cessation Furore made during the second preparation naltrexone, a drug to combat alcohol and drug addiction.
bupropion, the drug, which is responsible for Contrave for the possible heart cardiovascular disorders is already being used by about six million Americans each year, without resulting in serious heart cardiovascular side effects would have come.
"The ingredients of Contrave are products that enable doctors to operate since years and know them well," said Dr. Robert F. Kushner, clinical director of the obesity Center of Northwest University. He added that the condition for approval lies in a large-scale study , "a terrible and alarming signal to the entire industry," send.
A spokeswoman for the FDA said on the subject, that the authority had not yet decided in principle on whether cardiac cycle would require studies in the future on obesity drugs. Requested by the authorities at the present time such studies only of diabetes drugs, which has already led to smaller companies no longer provide research funds for this therapeutic area longer available - a clear loss of know-how. But there were just small companies that have come in the past with more convincing preparations on the market than the large, already somewhat sedate pharmaceutical companies.
In clinical studies Contrave had led to a slight increase in pulse rate and blood pressure. A warning sign that it also could increase the risk for heart attacks, strokes and other heart cardiovascular diseases easily. With the studies conducted by Orexigen to let such a suspicion, however, not confirm, but showed the patients in the group Contrave no signs of an increased risk compared with the placebo group . However, the FDA, the studies were applied to short and with too few patients carried out as that could have been anything but a huge additional risk can find.
This contrasts with the finding that obese and overweight patients because of their increased body weight per se a higher risk for heart and circulatory diseases and various other diseases are exposed. Even a slight weight reduction can risk of diabetes or other diseases reduce dramatically.
The FDA did, however, possibly because of the experience with sibutramine (Reductil) are forced to demand a large-scale study regarding the impact on the heart and circulatory system. Sibutramine (Reductil) was authorized in 1997 by the FDA for the market, although it was known even then that the drug's heart rate and blood pressure raised slightly. Last year, now has one by the European Medicines Agency (EMEA) required study shown that sibutramine (Reductil) actually increases the risk of heart attacks and stroke - but only for patients who already had a pre-existing damage to the heart -vascular system.
"It seems that the FDA would draw lessons from the past," said Dr. Sanjay Kaul, a cardiologist from Cedars-Sinai Medical Center in Los Angeles, welcomed the decision of the Authority. "The FDA apparently tried to give a warning to the pharmaceutical industry that it is not enough in the future just to package old drugs new," said Kaul, who had come out last December as a member of the Consultative Commission to impose Contrave. "The industry needs new, innovative ways to go, will bring them in the future a drug against obesity on the market. "
The question remains whether it not be better would be a drug like Contrave, its effectiveness in clinical studies undisputedly were moderate use to be able to the rampant obesity epidemic to be Lord at least in part, as to have no product and afterwards deal with the significantly higher cost of weight cause side effects must. The FDA has no ready answer to. She is silent, as always, to their decisions.
Source: swissestetix Blog
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