Sunday, June 1, 2008
CAT Scan Test Shows Zimulti (Rimonabant) Reduces Dangerous Abdominal Fat
Cat (CT) scans of obese patients treated with Acomplia/Zimulti (once approved in the United States) have confirmed for the first time that the diet drug significantly reduces the dangerous type of abdominal obesity that often leads to type 2 diabetes, according to researchers.
In a late-breaking report presented at the annual meeting of the European Atherosclerosis Society in Istanbul, the researchers said cat scans showed that rimonabant treatment for a year resulted in significantly greater reductions in visceral fat than a placebo and also helped reduce the fatty liver index.
The results came from the ADAGIO-LIPIDS clinical trial, a study conducted in 799 patients with abdominal obesity and with the high triglyceride - low HDL-cholesterol dyslipidemia. Dyslipidemia is a condition that contributes to the development of atherosclerosis (commonly called hardening of the arteries).
The purpose of the study, according to lead researcher Dr Jean-Pierre Després of Université Laval in Quebec City, was to determine the effect of rimonabant on HDL (good) cholesterol and triglyceride levels and on the cardiometabolic profile of overweight/obese patients with dyslipidemia.
Patients treated for a year with rimonabant, Després reported, saw their HDL cholesterol increased by an average 9.7% while triglycerides were lowered 15.5%. Blood pressure was reduced 3.3 mm Hg, and inflammation levels measured by C-reactive protein (CRP) were also reduced.
But for the first time in a rimonabant trial, patients were also given cat scans to measure how much subcutaneous and visceral fat was lost on rimonabant as well as to determine whether rimonabant could reduce liver fat.
"Although we had evidence from the phase III studies conducted with rimonabant that (the drug) could induce a reduction in waist circumference (a crude marker of abdominal fat) and improve several features of the metabolic syndrome, no study had ever quantified the effect of this drug on visceral adiposity and liver fat," Després said.
The researchers reported that rimonabant therapy for a year reduced visceral adipose tissue by an average 10.1%, which was greater than the 5.1 percent loss of subcutaneous fat, and produced a "significant: decrease in the fatty liver index.
"Results of ADAGIO-LIPIDS provide support to the notion that patients with visceral obesity who are often either dyslipidemic or with type 2 diabetes (or both) represent a relevant subpopulation of overweight/obese patients who would particularly benefit from rimonabant therapy," the researchers concluded.
In a late-breaking report presented at the annual meeting of the European Atherosclerosis Society in Istanbul, the researchers said cat scans showed that rimonabant treatment for a year resulted in significantly greater reductions in visceral fat than a placebo and also helped reduce the fatty liver index.
The results came from the ADAGIO-LIPIDS clinical trial, a study conducted in 799 patients with abdominal obesity and with the high triglyceride - low HDL-cholesterol dyslipidemia. Dyslipidemia is a condition that contributes to the development of atherosclerosis (commonly called hardening of the arteries).
The purpose of the study, according to lead researcher Dr Jean-Pierre Després of Université Laval in Quebec City, was to determine the effect of rimonabant on HDL (good) cholesterol and triglyceride levels and on the cardiometabolic profile of overweight/obese patients with dyslipidemia.
Patients treated for a year with rimonabant, Després reported, saw their HDL cholesterol increased by an average 9.7% while triglycerides were lowered 15.5%. Blood pressure was reduced 3.3 mm Hg, and inflammation levels measured by C-reactive protein (CRP) were also reduced.
But for the first time in a rimonabant trial, patients were also given cat scans to measure how much subcutaneous and visceral fat was lost on rimonabant as well as to determine whether rimonabant could reduce liver fat.
"Although we had evidence from the phase III studies conducted with rimonabant that (the drug) could induce a reduction in waist circumference (a crude marker of abdominal fat) and improve several features of the metabolic syndrome, no study had ever quantified the effect of this drug on visceral adiposity and liver fat," Després said.
The researchers reported that rimonabant therapy for a year reduced visceral adipose tissue by an average 10.1%, which was greater than the 5.1 percent loss of subcutaneous fat, and produced a "significant: decrease in the fatty liver index.
"Results of ADAGIO-LIPIDS provide support to the notion that patients with visceral obesity who are often either dyslipidemic or with type 2 diabetes (or both) represent a relevant subpopulation of overweight/obese patients who would particularly benefit from rimonabant therapy," the researchers concluded.
Labels: Acomplia, Weight Loss, Zimulti
Monday, February 4, 2008
FDA caution, 'research drought' cuts drug approvals
Source: By Julie Schmit, USA TODAY
Federal approvals of new drugs last year sank to the lowest in five years, a drop some industry analysts attribute to more cautious regulators and less innovation by drugmakers.
The Food and Drug Administration last year approved 17 new molecular entities — active ingredients that weren't marketed in the USA before.
The FDA also approved 65 original new drug applications last year, the fewest since 1999, according to data from BioMed Tracker of Sagient Research Systems.
Drug applications include new molecular entities as well as new formulations or new manufacturers of existing drugs. The FDA approved 64% of the applications it decided last year, down from 73% the year before, BioMed data show.
Industry analysts say the FDA is more cautious after drawing criticism in recent years for approving some drugs whose risks were found to outweigh their benefits after they went on the market. Examples include painkillers Vioxx and Bextra. Both are now off the market.
"It appears from the outside that the hurdles have been raised," says Michael Levesque, pharmaceutical analyst at Moody's Investors Service. (MCO)
The FDA may be less likely to approve drugs that lack clear advantages over older treatments and may carry unknown risks, adds Linda Bannister, health care analyst at Edward Jones.
Drugs that hit FDA roadblocks last year included diet drug Acomplia, also known as Zimulti in the USA. While pegged a potential blockbuster by industry analysts, an FDA panel in June recommended against its approval due to concerns it that increases the risk of suicidal thoughts. Sanofi-Aventis (SNY) then withdrew the application.
Potential approvals for depression drug Pristiq and schizophrenia drug Bifeprunox were both delayed after the FDA asked for additional data, Levesque says.
The FDA's standards for approving drugs haven't changed, spokesman Christopher DeFrancesco says. He says the rate of approvals to submissions remained steady at about 80% from 1997 through 2005.
Ira Loss of research firm Washington Analysis says the industry's "research drought" has led to weaker applications, thus fewer approvals. An explosion of drug discoveries started in the late 1980s, peaked in the mid-1990s, then "petered out."
Federal approvals of new drugs last year sank to the lowest in five years, a drop some industry analysts attribute to more cautious regulators and less innovation by drugmakers.
The Food and Drug Administration last year approved 17 new molecular entities — active ingredients that weren't marketed in the USA before.
The FDA also approved 65 original new drug applications last year, the fewest since 1999, according to data from BioMed Tracker of Sagient Research Systems.
Drug applications include new molecular entities as well as new formulations or new manufacturers of existing drugs. The FDA approved 64% of the applications it decided last year, down from 73% the year before, BioMed data show.
Industry analysts say the FDA is more cautious after drawing criticism in recent years for approving some drugs whose risks were found to outweigh their benefits after they went on the market. Examples include painkillers Vioxx and Bextra. Both are now off the market.
"It appears from the outside that the hurdles have been raised," says Michael Levesque, pharmaceutical analyst at Moody's Investors Service. (MCO)
The FDA may be less likely to approve drugs that lack clear advantages over older treatments and may carry unknown risks, adds Linda Bannister, health care analyst at Edward Jones.
Drugs that hit FDA roadblocks last year included diet drug Acomplia, also known as Zimulti in the USA. While pegged a potential blockbuster by industry analysts, an FDA panel in June recommended against its approval due to concerns it that increases the risk of suicidal thoughts. Sanofi-Aventis (SNY) then withdrew the application.
Potential approvals for depression drug Pristiq and schizophrenia drug Bifeprunox were both delayed after the FDA asked for additional data, Levesque says.
The FDA's standards for approving drugs haven't changed, spokesman Christopher DeFrancesco says. He says the rate of approvals to submissions remained steady at about 80% from 1997 through 2005.
Ira Loss of research firm Washington Analysis says the industry's "research drought" has led to weaker applications, thus fewer approvals. An explosion of drug discoveries started in the late 1980s, peaked in the mid-1990s, then "petered out."
Labels: Acomplia, Weight Loss, Zimulti
Sunday, January 20, 2008
Acomplia Works as a Weight Loss and Anti Smoking Pill
Not all discoveries are planned. Many a times results of research amaze the researcher itself. A similar instance was noticed when research was being undertaken on Acomplia for its weight loss properties. It was observed that the drug was helpful in reducing cravings for not only food but also smoking. This was a breakthrough discovery and was hailed by people all over the world.
Obesity and smoking are two of the most severe problems grappling the society today. Today obesity causes the most number of deaths worldwide, mainly in the form of cardio-vascular complications. Smoking too contributes to nearly 20% of all deaths. A single pill to deal with both these problems people are swooning over Acomplia s weight loss and anti-smoking properties.
Acomplia is the brand name of Rimonabant. Developed by Sanofi-Aventis, rimonabant works by blocking a pleasure centre. This pleasure centre would get titillated and thus patients would feel hunger pangs. Researchers at Sanofi-Aventis thought that if this pleasure centre were blocked, it would reduce cravings for food. When appetite is dampened, the patient will automatically lose weight. The idea for developing the pill came from the observations in people who smoked cannabis. After a joint of cannabis, the smokers experienced extreme hunger pangs.
Studying the cause of this led them to the body s Endocannabinoid system. Cannabinoid type I or CB1 receptors cause the hunger pangs. Thus, the idea of blocking the CB1 receptors arose. While the effectiveness of Acomplia has been fully ascertained on the weight loss front, research is still being undertaken on its anti smoking properties. On the weight loss front, the results of Acomplia have been impressive. Lancet, a medical journal of the UK published the results of a clinical trial conducted in 2005.
It was reported in the article that overweight people, who underwent trials lost weight significantly, with just five mgs of rimonabant or Acomplia. With 20 mgs of the drug, the weight loss was 10% or greater than those taking the placebo. Moreover, Acomplia has been found helpful in reducing waist measurements by doing away with the fat over the problem areas. Some of the other benefits of the drug are increasing insulin resistance and high density lipoprotein cholesterol. Acomplia has been approved for sale in the UK.
It still awaits approval by FDA in the US. Sanofi-Aventis is planning to launch rimonabant by the name of Zimulti rather than Acomplia. The patient must have been prescribed Acomplia by a certified doctor for purchasing the drug. The drug is available with several internet pharmacies. It is convenient to buy the drug from an online drug store. Moreover, buying Acomplia online helps maintain anonymity of patient. But beware of the fakes that are being sold over the internet. Always buy from a recognized pharmacy to get genuine Acomplia for weight loss and cessation of smoking.
Obesity and smoking are two of the most severe problems grappling the society today. Today obesity causes the most number of deaths worldwide, mainly in the form of cardio-vascular complications. Smoking too contributes to nearly 20% of all deaths. A single pill to deal with both these problems people are swooning over Acomplia s weight loss and anti-smoking properties.
Acomplia is the brand name of Rimonabant. Developed by Sanofi-Aventis, rimonabant works by blocking a pleasure centre. This pleasure centre would get titillated and thus patients would feel hunger pangs. Researchers at Sanofi-Aventis thought that if this pleasure centre were blocked, it would reduce cravings for food. When appetite is dampened, the patient will automatically lose weight. The idea for developing the pill came from the observations in people who smoked cannabis. After a joint of cannabis, the smokers experienced extreme hunger pangs.
Studying the cause of this led them to the body s Endocannabinoid system. Cannabinoid type I or CB1 receptors cause the hunger pangs. Thus, the idea of blocking the CB1 receptors arose. While the effectiveness of Acomplia has been fully ascertained on the weight loss front, research is still being undertaken on its anti smoking properties. On the weight loss front, the results of Acomplia have been impressive. Lancet, a medical journal of the UK published the results of a clinical trial conducted in 2005.
It was reported in the article that overweight people, who underwent trials lost weight significantly, with just five mgs of rimonabant or Acomplia. With 20 mgs of the drug, the weight loss was 10% or greater than those taking the placebo. Moreover, Acomplia has been found helpful in reducing waist measurements by doing away with the fat over the problem areas. Some of the other benefits of the drug are increasing insulin resistance and high density lipoprotein cholesterol. Acomplia has been approved for sale in the UK.
It still awaits approval by FDA in the US. Sanofi-Aventis is planning to launch rimonabant by the name of Zimulti rather than Acomplia. The patient must have been prescribed Acomplia by a certified doctor for purchasing the drug. The drug is available with several internet pharmacies. It is convenient to buy the drug from an online drug store. Moreover, buying Acomplia online helps maintain anonymity of patient. But beware of the fakes that are being sold over the internet. Always buy from a recognized pharmacy to get genuine Acomplia for weight loss and cessation of smoking.
Labels: Acomplia, Weight Loss, Zimulti
How does Acomplia work?
How does Acomplia work? In the following I’ll try to answer this question that probably is in everyone’s mind when following a diet with acomplia.
Acomplia works in a very unique way. It blocks receptors that would otherwise receive messages of hunger and transmit those messages to the brain. In other words, Acomplia is an appetite suppressant. Combined with a low calorie diet and adequate exercise, people who take Acomplia can lose weight safely.
Another benefit of Acomplia is that it appears to suppress cravings for addictive substances like nicotine. Research has shown that smokers who take drug Acomplia are more likely to quit smoking and to do so without the usual weight gain that is often associated with quitting. In addition, levels of certain risk factors for heart disease improved in subjects who were given Acomplia in clinical trials. In particular, HDL (good) cholesterol levels rose, and triglyceride levels decreased. Further, blood glucose was better regulated in subjects who took Acomplia, so it can help people with diabetes lose weight as well as improve blood levels of sugar and fat.
The generic name for Acomplia is Rimonabant. It is expected that Sanofi-Aventis will call the drug Zimulti in the United States if it is approved for sale there. At the moment, the FDA is carefully examining data about Rimonabant in order to determine its safety and effectiveness as a treatment for obesity.
Acomplia works in a very unique way. It blocks receptors that would otherwise receive messages of hunger and transmit those messages to the brain. In other words, Acomplia is an appetite suppressant. Combined with a low calorie diet and adequate exercise, people who take Acomplia can lose weight safely.
Another benefit of Acomplia is that it appears to suppress cravings for addictive substances like nicotine. Research has shown that smokers who take drug Acomplia are more likely to quit smoking and to do so without the usual weight gain that is often associated with quitting. In addition, levels of certain risk factors for heart disease improved in subjects who were given Acomplia in clinical trials. In particular, HDL (good) cholesterol levels rose, and triglyceride levels decreased. Further, blood glucose was better regulated in subjects who took Acomplia, so it can help people with diabetes lose weight as well as improve blood levels of sugar and fat.
The generic name for Acomplia is Rimonabant. It is expected that Sanofi-Aventis will call the drug Zimulti in the United States if it is approved for sale there. At the moment, the FDA is carefully examining data about Rimonabant in order to determine its safety and effectiveness as a treatment for obesity.
Labels: Acomplia, Weight Loss, Zimulti
Sunday, December 2, 2007
Class-Action Lawsuit Filed Against Sanofi Over Zimulti
A major class-action law firm has filed suit against Sanofi-Aventis alleging that the French pharmaceutical company misled U.S. investors about prospects for diet drug rimonabant.
Coughlin Stoia Geller Rudman & Robbins LLP said on November 13 it had commenced action on behalf of an institutional investor in the U.S. District Court for the Southern District of New York.
Acomplia had been touted by Sanofi as a potential $5 billion blockbuster drug, but while approved in Europe in mid-2006, an application to sell the drug in the U.S. was pulled by Sanofi after an FDA expert advisory committee raised concerns about depressive and suicidal side-effects.
With no prospect that the drug will make it to the U.S. market for several years, sales of Acomplia have been anemic, totalling only $30 million in the third-quarter of this year.
The complaint alleges that Sanofi's statements regarding Zimulti -- the name the drug was to have been sold under in the U.S. -- were materially false and misleading when made because the company concealed data concerning Zimulti’s propensity to cause depression.
Coughlin Stoia Geller Rudman & Robbins LLP said on November 13 it had commenced action on behalf of an institutional investor in the U.S. District Court for the Southern District of New York.
Acomplia had been touted by Sanofi as a potential $5 billion blockbuster drug, but while approved in Europe in mid-2006, an application to sell the drug in the U.S. was pulled by Sanofi after an FDA expert advisory committee raised concerns about depressive and suicidal side-effects.
With no prospect that the drug will make it to the U.S. market for several years, sales of Acomplia have been anemic, totalling only $30 million in the third-quarter of this year.
The complaint alleges that Sanofi's statements regarding Zimulti -- the name the drug was to have been sold under in the U.S. -- were materially false and misleading when made because the company concealed data concerning Zimulti’s propensity to cause depression.
Thursday, June 14, 2007
Advisory Panel 14 - Zimulti 0
An FDA advisory panel of outside experts voted 14-to-0 that based on data provided to date, it was impossible to conclude that rimonabant has a "favorable risk-benefit profile," and recommended that Zimulti not be approved to aid weight loss by obese and overweight individuals.
If this was a baseball game (or even football game), that score adds up to a real bad day for Sanofi-Aventis.
A final decision is expected by July 27 by the FDA.
If this was a baseball game (or even football game), that score adds up to a real bad day for Sanofi-Aventis.
A final decision is expected by July 27 by the FDA.
Monday, June 11, 2007
Suicide a Potential Risk with Zimulti
The FDA has reported that patients who took Zimulti in clinical trials were more likely to report suicidal thoughts or actions than others who got a placebo, drug reviewers said in an analysis released Monday.
This comes one day before an advisory panel is scheduled to meet regarding the safety of the weight loss drug produced by Sanofi-Aventis, known as Acomplia in other parts of the world where it is being sold.
Food and Drug Administration staff also said the 20-milligram dose of the drug, Zimulti, produced clinically significant weight loss.
This comes one day before an advisory panel is scheduled to meet regarding the safety of the weight loss drug produced by Sanofi-Aventis, known as Acomplia in other parts of the world where it is being sold.
Food and Drug Administration staff also said the 20-milligram dose of the drug, Zimulti, produced clinically significant weight loss.
Sunday, June 10, 2007
Maker of Zimulti Has A Big Week Ahead
On Tuesday, June 12th, the FDA will for the first time reveal its views on the long-delayed diet drug Zimulti (Acomplia to the rest of the world).
The next day (June 13th), the agency's Endocrinologic and Metabolic Drug Advisory Committee, a panel of outside experts, will air various concerns about Zimulti/Acomplia and its side-effects, and vote on whether to recommend FDA approval.
Zimulti is predicted to be a blockbuster drug once approved in the United States, with sales estimates as high as $5 Billion in annual sales.
As news comes in, we'll keep you posted.
The next day (June 13th), the agency's Endocrinologic and Metabolic Drug Advisory Committee, a panel of outside experts, will air various concerns about Zimulti/Acomplia and its side-effects, and vote on whether to recommend FDA approval.
Zimulti is predicted to be a blockbuster drug once approved in the United States, with sales estimates as high as $5 Billion in annual sales.
As news comes in, we'll keep you posted.
Monday, June 4, 2007
UAE Approves Rimonabant (Acomplia/Zimulti)
The United Arab Emirates (UAE) became the first country to launch Acomplia/Zimulti in the Middle East.
A recent survey found that 37 percent of the UAE population is now obese -- one of the highest obesity rates in the Middle East, according to Sanofi.
"Among people who are overweight or obese, it is those with excess fat around their abdomen who are at the greatest risk of developing an abnormal lipid profile, type 2 diabetes and ultimately heart disease," said Dr. Wael Al Mahmeed, Vice President of the Emirates Cardiac Society.
A recent survey found that 37 percent of the UAE population is now obese -- one of the highest obesity rates in the Middle East, according to Sanofi.
"Among people who are overweight or obese, it is those with excess fat around their abdomen who are at the greatest risk of developing an abnormal lipid profile, type 2 diabetes and ultimately heart disease," said Dr. Wael Al Mahmeed, Vice President of the Emirates Cardiac Society.
Labels: Acomplia, Weight Loss, Zimulti
Wednesday, May 30, 2007
Will Avandia's Pitfalls Affect Zimulti's Approval?
Rumblings throughout the Pharma industry and Wall Street are predicting that the recent setback of Avandia (a diabetes drug produced by GSK) will adversely affect the anticipated approval of Zimulti in the United States this summer.
The FDA has a history of allowing current events and isolated incidents to sway their decisions, especially since Zimulti and Avandia (though not the same drug classification and treatment class) can both be considered 'Metabolic Syndrome' type drugs.
Time will tell... I just hope that the historical facts presented on June 13th are the deciding factor for the anticipated late July approval date, not the 'buzz' of current events.
The FDA has a history of allowing current events and isolated incidents to sway their decisions, especially since Zimulti and Avandia (though not the same drug classification and treatment class) can both be considered 'Metabolic Syndrome' type drugs.
Time will tell... I just hope that the historical facts presented on June 13th are the deciding factor for the anticipated late July approval date, not the 'buzz' of current events.
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