Weight Loss Drugs - weight loss information

The European Medicines Agency has warned consumers that the weight loss drug Acomplia heightens the risk of suicide among those taking anti-depressants.

The agency wants stronger warnings placed on the drug to reflect that risk but has stopped short of suspending the drug.

The agency says though the benefits of Acomplia outweigh its risks, it should not be used under any circumstances in patients with ongoing major depression or those who are taking antidepressants.

The panel has also called for a new warning on Acomplia's label to state that treatment should be stopped if a patient develops depression.

Information regarding the updated information will be sent to all doctors as the agency says it is important patients and their carers are aware of the risk of depression with the drug.

The move is in line with that of an advisory panel to the Food and Drug Administration (FDA) in the U.S. which has said the product should not be approved because it may increase suicidal thinking and depression.

The FDA decision was the result of a study which found that of 120 patients taking the drug, two had committed suicide and one was considering it, while another attempted to strangle his daughter.

Since that decision drug company Sanofi has withdrawn its application to sell Acomplia in the United States; it has been available under the brand name Zimulti in Europe since the middle of last year.

European officials are likely to allow the drug to remain on the market but with stricter warnings.

Acomplia is the first in a new class of drugs that work by switching off the same brain circuits that make people hungry when they smoke cannabis and it was forecast to become a multibillion dollar blockbuster.

More than 40,000 Britons have been treated with Acomplia since last year which was lauded as a wonder drug after trials showed it could help dieters lose up to 10 per cent of their body weight and also help smokers quit.

The Medicines and Healthcare Products Regulatory Agency in the UK says to date there have been 318 cases of patients being adversely affected by Acomplia.

Source: http://www.news-medical.net/?id=27891

The FDA is set to release results of their review of a weight loss pill called Acomplia which is manufactured by French drug maker Sanofi-Aventis.

The FDA is getting set to release results of their review of a new weight loss drug that is already approved for use in Europe.

Acomplia is the name of the drug which is manufactured by Sanofi-Aventis and on Wednesday of this week, an expert advisory panel is set to meet to discuss the drug.

"With the initial demand for Acomplia likely to be massive, the known neuropsychiatric side effects may make it difficult for the FDA to see a positive risk-benefit ratio," wrote Citigroup analyst Kevin Wilson in a Thursday note.

The decision handed down by the advisory panel may have a big impact on the FDA's final decision. Although they do not have to agree with their expert advisory panels, they often do.

Studies of the Acomplia drug have reported some symptoms such as depression, insomnia and anxiety in patients who take it, thus whether or not the drug will be approved by the FDA is anybody's guess.

Last February, the FDA denied Sanofi's application for their drug to be used as an anti-smoking pill stating that they needed more information before approving it.

Source: http://www.dogflu.ca/06102007/21/fda_reviewing_acomplia_drug

Sanofi-Aventis investors should brace for trading volatility next week when U.S. regulators reveal their review of the company's highly anticipated weight loss drug.

The French pharmaceutical company seeks Food and Drug Administration approval of Acomplia, a drug approved in Europe for fighting obesity.

The FDA is set to release its Acomplia review ahead of a Wednesday meeting at which outside experts will vote on whether it should be approved. The agency does not have to follow the experts' vote, though it often does.

The drug is considered a potential blockbuster despite hitting several regulatory bumps that have left some on Wall Street questioning its sales prospects.

"With the initial demand for Acomplia likely to be massive, the known neuropsychiatric side effects may make it difficult for the FDA to see a positive risk-benefit ratio," wrote Citigroup analyst Kevin Wilson in a Thursday note.

In recent weeks, the FDA has been widely criticized over a lag in getting new safety data about a GlaxoSmithKline diabetes drug to the public.

Analysts say that controversy might give regulators pause at approving a new drug with potentially dangerous side effects. Studies of Acomplia have shown instances of depression, insomnia and anxiety in patients who take it.

Wilson predicts that the FDA's review of the drug will likely focus more on safety than effectiveness, driving Sanofi's stock down in the first part of the week.

Sanofi originally touted Acomplia as both an anti-obesity pill and an anti-smoking treatment because it stops cravings associated with addictive behavior.

Last February, however, the FDA rejected the company's application for the anti-smoking use and said it needed more information before approving the drug to fight obesity.

The drug gained approval in the European Union soon after, but regulators there also did not approve the smoking use and limited approval to overweight patients who suffer additional health problems, including abnormal cholesterol and diabetes.

Even so, sales there soared to $20 million in the first quarter of 2007, and Sanofi said more than 130,000 people have used the drug since its European launch.

If approved in the U.S., Sanofi said it would market the drug under the name Zimulti, because FDA reviewers felt the name Acomplia could potentially mislead consumers.

Shares of Sanofi-Aventis rose 5 cents to $45.28 Friday in midday trading.

Source: http://www.chron.com/disp/story.mpl/ap/fn/4873677.html

Indian generic firms Torrent Pharma, Zydus Cadila and Sun Pharma, that have launched versions of Sanofi-Aventis’ anti-obesity drug Acomplia (rimonabant) in India, seem unperturbed by the imminent launch of the drug in India.

Sanofi-Aventis has applied for a patent protection for Acomplia here.

Since a patent holder cannot block the generics already available in the market, experts opine that Sanofi-Aventis can ask for a royalty from the generic companies once it is granted patent for rimonabant. However, Indian firms are of the view that since Rimonabant is a pre-1995 molecule, they are not entitled to pay royalty to Sanofi-Aventis.

In May, Torrent and Cadila launched the generic versions of Acomplia in India, named Remoslim and Slimona respectively. Sun Pharma has also launched two drugs, Riocity and Riobec.

Ruchir Modi, VP, marketing, Torrent said, “Rimonabant was discovered by Sanofi before 1995, thus Sanofi is not entitled to obtain product patent as per the patents laws of India. Hence, the question of paying royalty to Sanofi does not arise.” Torrent Pharma is aiming to clock Rs 10 crore in sales in the first year of its launch.

Source: http://www.financialexpress.com/fe_full_story.php?content_id=166520

Sanofi-Aventis announced the launch of Acomplia (rimonabant), their new scientific drug for the treatment of abdominally obese patients with cardio metabolic risk cluster.

Acomplia has received approval from the European Medicines Evaluation Agency (EMEA) to be used in combination with diet and exercise for the treatment of abdominal obesity with cardio metabolic risk cluster, and is already sold in over 12 European countries, including Germany and the UK.

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How is it possible that mid-sized Indian pharmaceutical companies are already selling their own versions of diet drug rimonabant in India while the original developer of the drug, Sanofi-Aventis, still doesn't have Indian government approval to sell Acomplia?

Well, part of the answer may be that Sanofi was so focused on getting approval to sell the drug in Europe (where Acomplia went on sale last summer) and in the United States (where it still awaits regulatory action) that the French pharmaceutical giant was late in filing for marketing authorization in India.

While a Sanofi spokesperson said the company filed last summer with India's Central Drugs Standard Control Organization, which regulates the market authorization of new drugs as well as the standards for imported drugs, Sanofi confirmed that the Indian regulatory agency has not yet acted on Acomplia.

"It's too soon to tell what will be our strategy regarding the launch of Acomplia in India,'' a Sanofi spokesperson told Bloomberg News last week.

Given the relatively high cost of the drug -- generally somewhat more than US$100 per month -- in the dozen plus countries where Acomplia is already on sale, Sanofi may have thought the number of Indians who would be able to afford a price of this magnitude would be relatively small.

But in the meantime, Indian pharmaceutical companies that seem to have replicated Sanofi's version of the rimonabant molecule -- which apparently was never granted patent protection in India -- independently filed with the regulatory agency and received approval to sell their own versions of the drug.

With at least two companies -- Torrent Pharmaceuticals and Zydus Cadila -- already selling Rimoslim and Slimona in India for under US$6 per month, the market for rimonabant in a country that has a growing urban, middle-class obesity problem may turn out to be significantly greater than Sanofi believed.

Source: http://www.dietdrugreport.com/News/news-052707.htm

Diet pills aim to help overweight people to curb their hunger and therefore lose weight. They are invariably pharmacological substances, though herbal and other natural alternatives exist, too. If diet pills contain pharmacological agents, there is an issue of benefits vs. risks involved. Obviously, grossly obese patients with serious health risks caused by excessive weight do not have many options. However, many of the initially developed diet pills contained amphetamines. Examples of these were Dexedrine and Digoxin. These stimulants can increase heart rates to dangerous levels. Obese persons often have to reduce weight precisely because of existing or developing heart conditions. In this context, diet pills that contain amphetamines or similar stimulants present a definite risk. While they do curb hunger, they also disrupt normal sleep patterns, cause anxiety and are highly addictive. Their uncontrolled use leads to many serious problems. In fact, almost all diet pills work by disrupting some natural physical and even mental functions. This is an important point to remember.

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With weight loss craze on the rise, people are resorting to various diet pills available in the market. Acomplia, a recently launched diet pill is creating waves in the ever-growing weight loss market. It is developed by Sanofi-Aventis, a large cap French pharma. Acomplia is a short-term obesity management, which is to be used in alliance with a weight loss schedule.

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It's now official. If diet drug Acomplia (rimonabant) is ultimately approved for sale in the United States, the prescription diet pill will go on the U.S. market not as Acomplia but as Zimulti.

Sanofi-Aventis, developer of rimonabant which is now sold in a number of European countries, Argentina and Mexico as Acomplia, has long been coy about what name it intends to use if the FDA approves the diet drug for U.S. sale.

But the pros-and-cons of rimonabant are cheduled to be aired by an FDA advisory panel on June 13th, and the official notice of the hearing published in the Federal Register says the panel will discuss "the efficacy and safety of new drug application (NDA) 21-888, proposed tradename Zimulti (rimonabant)."

The meeting notice published by the FDA Endocrinologic and Metabolic Drugs Advisory Committee also is interesting in that would appear to dash suggestions made by some of Sanofi's favorite financial analysts that the FDA may now approve Acomplia / Zimulti for treatment of type 2 diabetes.