Rimonabant Acomplia Blog

FDA's Acomplia Review Delayed Until July 27

2007-02-14T05:24:00.000-08:00

http://www.forbes.com/
"Sanofi-Aventis said the US Food and Drug Administration has extended its review of anti-obesity drug Acomplia by three months to July 27.
In December, Sanofi had said it expected the FDA's decision by April 26."
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France Recommends Acomplia Reimbursement

2007-02-09T14:23:00.000-08:00

http://www.forbes.com/
"Sanofi-Aventis said its Acomplia drug has received a 'favourable recommendation' from the independent Transparency Committee in France for reimbursement by health insurance companies and state social security plans when prescribed for diabetic, obese patients.

The next stage is for the government to decide if it will follow this recommendation and then the proportion of the cost to be refunded."

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Australian Acomplia Study

2007-01-27T07:11:00.000-08:00

http://www.thewest.com.au/
"Perth researchers will test a new anti-obesity pill on West Australians in the hope it will not only help them lose weight but reduce their risk of heart disease by boosting levels of HDL, or “good” cholesterol.

The Royal Perth Hospital study, part of an international trial, could prove the weight-loss pill rimonabant, sold as Acomplia, can help ward off the condition known as metabolic syndrome, a particularly highrisk form of obesity which entails problems controlling blood pressure, cholesterol and insulin.

RPH professor of medicine Gerald Watts, who specialises in metabolic disorders, said the drug was expected to be approved for Australia within a few months and the hospital aimed to recruit 15 to 20 patients as part of the 80 being studied worldwide.

“We’re interested in the mechanism of how this drug works and the role it could play in obese people who have several risk factors for heart disease, one of which is low HDL cholesterol, or metabolic syndrome,” he said. "
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Sanofi To Challenge Acomplia Decision By German Court

2007-01-16T06:13:00.000-08:00

http://www.pharmatimes.com/
"Sanofi-Aventis says that it intends to challenge in the courts the decision made by the German Ministry of Health which states that the firm's anti-obesity drug Acomplia will not be reimbursed.

The Ministry of Health has upheld a recommendation from the German Federal Joint Committee, the G-BA, which said in October that it believes funding treatment with Acomplia (rimonabant) is inappropriate because it is a 'lifestyle' drug, a viewpoint which Sanofi disagrees with vigorously.

The French drugmaker has argued that Acomplia should be covered because it helps lower the risk of developing diabetes and cardiovascular disease, in addition to aiding weight loss. Indeed, Sanofi recently presented data from a Phase III trial of Acomplia which shows that treatment-naive patients with type 2 diabetes who received the drug experienced significant improvements in blood glucose control and weight loss, compared to those who took placebo."
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Will Rimonabant Be Used To Treat Drug Addiction?

2007-01-15T06:14:00.000-08:00

http://www.rivistaonline.com/
"Proven that testing is working, the pill won't treat marijuana lighter users. Mr Lucchini points out the Federsed is intended to make use of it in order to treat "troublesome addictions". The drug is not aimed just to marijuana but also to hard cocaine and heroine addicts. Furthermore, the Sanofi Aventis, the Rimonabant International Company producer, shall be also available to allow a change in the drug public image, passing from a fat treatment to a drugs treatment pill. A multibillionaire contract offered by the state is always attracting; the Sanofi, however, may decide not to get involved with drugs and be satisfied with the 5 billion dollars it is certain to gain through the obesity treatment pill selling within 2010. Nevertheless, a question remains unanswered: is it reasonable to treat drugs addicts with a pill? On one side, there are the supporters of medical treatment considered as the only way-out for drug users, in constant search for a pharmacologic solution to pains and troubles of social order. On the other, the drugs-as-choice and result-of-discontent supporters. But society who produces discontent can hardly be treated with drugs. Federsed promised to explain his reasons on a press conference due to be arranged in near future: the conference will be coupled with a left-leaning manoeuvre by the ruling government aimed to a progressive reassessment of the national drugs law. We wait for what is next .
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How Rimonabant Can Help You Lose Weight

2007-01-09T05:50:00.000-08:00

http://www.newswise.com/

"Blocking cannabinoid receptors may dampen an overactive EC system, reining in appetite, reducing weight, and improving obesity-related risk factors for heart disease and type 2 diabetes.

A drug that blocks cannabinoid receptors, rimonabant (Acomplia), is being considered by the U.S. Food and Drug Administration (FDA) to treat people with type 2 diabetes. Four similar drugs are also in the pipeline. “We’ve seen that blocking these receptors results not only in reduction of food intake, but also a reduction in triglycerides and glucose, and even an increase in ‘good’ HDL cholesterol. And that’s above and beyond any reduction in weight,” says Dr. Aronne.

A recent review of four placebo- controlled clinical trials of rimonabant found it produces only moderate weight loss. But even the average 5 percent weight loss seen in the trials after one year of using 5 mg of rimonabant reduced risk factors for type 2 diabetes and cardiovascular disease, according to the October 17, 2006 edition of The Cochrane Library.

A higher dose (20 mg) produced a larger weight loss, almost 11 pounds, as well as a reduction in waist circumference, triglycerides, blood pressure, and raised low HDL cholesterol. These are all risk factors for metabolic syndrome, notes Dr. Aronne.

“In the clinical trial conducted in North America, there was a 39 percent reduction in metabolic syndrome prevalence in the rimonabant group versus 8 percent in the placebo group.” However, the higher dose also produced more side effects such as dizziness, nausea, headache, and depressed mood."

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FDA Will Review Acomplia April 26

2007-01-04T06:03:00.000-08:00

http://www.fool.com/
"On Friday, Sanofi announced that the FDA has set April 26 as the new date to review Acomplia and give Sanofi a thumbs-up or -down on marketing it in the U.S. Back in February, the drug received an approvable letter for its weight-loss indication and was deemed non-approvable as a treatment to help people stop smoking.

Acomplia was approved in the European Union back in late June, but the U.S. is where the big money is, especially now that France and Germany have been enacting new measures such as higher taxes on drug sales and rules to encourage doctors to prescribe cheaper prescriptions or generic drugs.

Since the limited launch of the drug in the EU in the third quarter, Acomplia sales have been roughly $15 million. But sales should increase much faster as Sanofi gets the word out about Acomplia via marketing and other measures."

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Another Rimonabant Article

2007-01-03T04:51:00.000-08:00

http://www.cbc.ca/
"Rimonabant works by blocking cannabinoid receptors in the brain that cause cravings. It also affects other organs such as the liver and pancreas that control blood fats and insulin levels.

It works differently than other anti-obesity drugs but seems to have many of the same side-effects, such as nausea and diarrhea. People taking rimonabant also have a tendency to get anxious and depressed."

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FDA To Rule On Acomplia In Spring 2007

2006-12-16T06:54:00.000-08:00

http://www.norml.org/
"US regulatory authorities have announced that they will decide this spring on whether to approve the prescription use of the cannabinoid receptor antagonist SR 141716A, to be marketed by Sanofi-Aventis Pharmaceuticals as a diabetes treatment and anti-obesity drug under the trade name Acomplia (Rimonabant). In July, the selective cannabinoid blocking agent received regulatory approval in a handful of European nations as a dietary aid. Acomplia is the first cannabinoid antagonist ever to be approved for human consumption.

The US Food and Drug Administration (FDA) will review newly published clinical data indicating that Acomplia significantly lowers blood sugar levels in humans compared to placebo. The FDA had previously denied Sanofi permission to market Acomplia in the United States."

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FDA To Rule On Acomplia In Spring 2007

2006-12-16T06:53:00.001-08:00

Acomplia Before Obesity Surgery

2006-12-16T06:53:00.000-08:00

http://www.bloomberg.com/
"Obese people should receive drugs such as Sanofi-Aventis SA's Acomplia and surgery only as a last resort, a U.K. government panel that assesses the cost effectiveness of therapies said today.

Surgery shouldn't be considered for most morbidly obese adults, the National Institute for Health and Clinical Excellence, which advises the National Health Service of England and Wales, said in its new treatment guidelines. Drugs are recommended only if the patient has complicating factors such as sleep apnea or a psychological condition"

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Sanofi Completes Class 2 Response For Acomplia

2006-12-09T06:47:00.000-08:00

http://www.earthtimes.org
"Sanofi-aventis announces that concerning the New Drug Application for rimonabant in the United States, the Food and Drug Administration has considered its October 26, 2006 resubmission to be a complete, class 2 response to the FDA February 17, 2006 action letter."

The user fee goal date is April 26, 2007. About Rimonabant
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Data Findings of Rimonabant Serenade Trial

2006-12-09T06:46:00.000-08:00

http://biz.yahoo.com/
"In the SERENADE study, treatment-naive type 2 diabetes patients receiving rimonabant 20mg per day for a duration of six months significantly lowered their HbA1c levels by 0.8% from a baseline value of 7.9 as compared to a reduction of 0.3% in the placebo group (p=0.002). In addition, patients with an HbA1c level greater than or equal to 8.5% at baseline, significantly reduced their HbA1c by 1.9% with rimonabant as compared to 0.7% with placebo (p<0.0009). acomplia
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The Acomplia Serenade Trial

2006-12-09T06:45:00.000-08:00

http://www.forbes.com/
"The trial, known as SERENADE, found Acomplia -- a CB-1 agonist -- reduced HbA1c and triglyceride levels and increased HDL levels in type 2 diabetes patients who took it as a monotherapy for six months. The study results were presented Tuesday at the World Diabetes Congress in Cape Town, South Africa.

Bank of America analyst Chris Schott said he thinks the results of the study could aid in winning reimbursement for Acomplia. Although the treatment has been approved for marketing in Europe, Germany recently declined reimbursement for the drug.

'We believe data from SERENADE as well as RIO-Diabetes could support broader reimbursement for Acomplia, especially as its efficacy appears in line with other oral diabetes agents,' Schott stated in a research report Tuesday."

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More On The Rimonabant Serenade Trial

2006-12-06T05:31:00.000-08:00

http://www.medicalnewstoday.com/
"The trial achieved not only significant reduction in blood sugar levels but also in patient body weight - 6.7 kg compared to 2.7 kg in the placebo group. Results also showed improvements in (good) HDL cholesterol and triglicerides. This is unlike many currently approved diabetes treatments, where weight gain is a common and unwelcome side effect.

"This study suggests that rimonabant can achieve improvement in blood glucose with the added benefit of significant weight loss and improvement in other risk factors" said trial investigator Julio Rosenstock, MD, Director of the Dallas Diabetes and Endocrine Center at Medical City and Clinical Professor of Medicine at the University of Texas Southwestern Medical School, Dallas.

Nearly 300 patients throughout the US and six other countries took part in the SERENADE trial. The drug rimonabant is not currently available in the US although it has been approved in Europe."
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Acomplia: The Serenade Study

2006-12-06T05:30:00.000-08:00

http://www.forbes.com/
"The Serenade study evaluated Acomplia for diabetes treatment, with the drug lowering blood sugar levels while also reducing a patient's weight. Other Sanofi studies had looked primarily at the drug's ability to promote weight loss.

Green declined to comment on when Acomplia might be approved in the US. Sanofi had hoped for approval by the end of this year, but the US Food and Drug Administration recently asked for more information, which many analysts expect to push back approval by several months.

Acomplia is slated to become a new blockbuster drug for Sanofi, with over 1 bln eur of annual sales. Investors hope it will help shore up a product portfolio that has a number of drugs facing generic competition over the coming years."

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Acomplia Update

2006-11-25T18:06:00.000-08:00

http://www.businessweek.com/
"As if all that weren't enough, FDA approval for the company's long-awaited anti-obesity treatment, Acomplia, has been delayed until next spring. "It's just the latest setback for a volatile company that's struggling with a lot of issues," says Navid Malik, a pharmaceutical analyst with London-based brokerage Collins Stewart.

With troubles mounting, Sanofi is under intense pressure to get Acomplia onto the U.S. market—fast. Hailed by analysts as a potential multibillion-dollar blockbuster, Acomplia is critical to the company's future growth. Also known as rimonobant, the drug is the first in a new class of medicines that curtail cravings by blocking receptors known as cannabinoid type 1 (CB1) found in the brain and in fat tissue. CB1 receptors influence hunger and addictions, such as to nicotine.

Clinical trials indicate that Acomplia not only could help people lose weight but also shrink abdominal fat and help them stop smoking. Even more remarkably, it can also improve cholesterol levels and blood-sugar control. That means Acomplia might also someday be used in treating diabetes, though approval for that application remains years off, pending results of tests now under way. "

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Rimonabant-Acomplia Press Release

2006-11-25T18:04:00.000-08:00

http://www.prweb.com/
"Rimonabant-Acomplia (discovered and developed by Sanofi-Aventis) is a CB1 endocannabinoid receptor antagonist. CB1 blockers act on the endocannabinoid system, a system controlling energy and nicotine dependence, reducing the overstimulation thought to lead to obesity and nicotine addiction. In a recent study, 1,036 overweight or obese patients with blood lipid disorders were randomly placed in one of three groups (placebo vs. 5 mg or 20 mg per day of Rimonabant-Acomplia). After one year of treatment, patients receiving 20 mg per day of Rimonabant-Acomplia lost an average of 20 pounds, compared to only 5 pounds for patients on placebo. Further comparisons between the placebo and 20 mg per day Rimonabant-Acomplia group showed that the latter patients enjoyed significant improvements in waist circumference and HDL-C and triglyceride levels, all important factors in maintaining heart health. The drug was said to be well tolerated, with only mild and transient side effects like dizziness and gastrointestinal distress. The drug is currently only approved for sale in Europe, with a date for U.S. availability still uncertain."

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Acomplia To Be Reimbursed In Sweden

2006-11-14T06:07:00.000-08:00

http://www.pharmalive.com/
"Sanofi-aventis announced today that Acomplia™ (rimonabant) recently approved in the 25 countries of the European Union was granted reimbursement by the Pharmaceutical Benefits Board (PBB) of Sweden for treatment of obese patients with BMI over 35 kg/m2 or overweight patients with BMI over 28 kg/m2 and type-2 diabetes or dyslipideamia. Acomplia™ is available for patients in Sweden as of today

Swedish reimbursement of Acomplia™, the first-in-class medicine that targets multiple cardiometabolic risk factors, is the third reimbursement obtained in Europe in a month and completes the reimbursements obtained in Denmark and Ireland "

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Acomplia Approved In Mexico

2006-11-10T06:19:00.000-08:00

http://www.euro2day.gr/
"Sanofi-Aventis said Mexico''s health ministry has approved the obesity treatment Acomplia for commercial sale, the first North American country to do so.
The move comes after concerns arose that the US Food and Drug Administration (FDA) could take several months longer than planned with its decision on Acomplia.
Sanofi-Aventis recently declined to comment on the FDA''s timetable."
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More Acomplia Data

2006-11-10T06:18:00.000-08:00

http://www.itp.net/
"Sanofi-aventis’ drug rimonabant (Acomplia) may aid in controlling blood sugar levels in type-2 diabetes, offering a new avenue in diabetes management, reports a new study.

Results from the year-long RIO-Diabetes trial, published in The Lancet, found that rimonabant 20 mg once daily significantly improved several cardiometabolic risk factors in patients whose diabetes was uncontrolled by metformin or
sulfonylurea. Improvements were recorded in weight, HbA1c, HDL- cholesterol, triglycerides, systolic blood pressure and waist circumference.

50% of the improvements in HbA1c and HDL-cholesterol levels were independent of the weight loss achieved, indicating a direct effect of rimonabant on these parameters, say authors."
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Acomplia Now Available In Ireland

2006-11-05T06:01:00.000-08:00

http://media.netpr.pl/
"Sanofi-aventis Ireland Ltd. announced today, that ACOMPLIA(R) (rimonabant 20mg/day), is available from today, 1st November 2006.

ACOMPLIA(R) is the first in a new class of drugs that target cardiometabolic risk factors such as abdominal obesity, insulin resistance, cholesterol and elevated triglycerides(i). It is licensed for use as an adjunct to diet and exercise for the treatment of obese patients (BMI greater than or equal to 30kg/m2), or overweight patients (BMI >27kg/m2) with associated risk factors, such as type 2 diabetes or dyslipidaemia(1).

Ireland is the third country in the world to have launched ACOMPLIA(R) and the treatment has been welcomed by physicians across the country.

"Rimonabant (Acomplia) addresses the multiple cardiometabolic risk factors that put patients at risk for cardiovascular disease and type 2 diabetes" said Dr. Seamus Sreenan, Consultant Endocrinologist, Connolly Hospital, Blanchardstown, Dublin 15. He continued "ACOMPLIA(R) is an important advancement which will offer benefits beyond current treatments for individual risk factors such as blood pressure, cholesterol and diabetes and I applaud the foresight of early access to this valuable medicine for patients in Ireland".

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Sanofi Sponsors Two Year Acomplia Study In East Texas

2006-11-02T05:05:00.000-08:00

http://www.zwire.com/

The pharmaceutical firm Sanofi-Aventis is sponsoring the two-year trial of the drug, rimonabant. Dr. David Shafer, director of UTHCT's Center for Diabetes Care, is the principal investigator of the study at UTHCT.

The study seeks to enroll 6,000 people who are at high risk of diabetes and live in Texas, Louisiana or California. The health center - the only East Texas institution participating in the study - hopes to recruit at least 30 of those patients, Shafer said.

Individuals enrolled in this double-blind study will be followed for two years to determine whether the drug helps prevent diabetes, information from the health center stated. "

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New Rimonabant Study Results

2006-11-02T05:03:00.000-08:00

http://www.forbes.com/
"After a year, Scheen's team found that patients taking rimonabant lost significantly more weight than those taking the placebo. Patients on placebo lost an average of 1.4 kilograms, compared with 2.3 kilograms for those given 5 milligrams per day and 5.3 kilograms in patients taking 20 milligrams per day. (For conversion, one kilogram is equal to just over 2 pounds.)
In addition, patients taking rimonabant had greater improvement in waist size, blood sugar control, cholesterol, and better appetite control, compared with patients receiving placebo, the researchers report.
"These findings support the use of 20 mg per day of rimonabant, in addition to diet and exercise, as a new approach to reduce body weight and improve blood glucose control as well as several other cardiovascular risk factors in overweight or obese patients with type 2 diabetes that was inadequately controlled by standard treatment," the researchers concluded."
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Acomplia Needs More Tests To See If It Helps Diabetes

2006-11-02T05:01:00.000-08:00

http://www.bloomberg.com/apps/news?pid=20601085&sid=apyjYwLX4kfI&refer=europe

"Sanofi-Aventis SA, Europe's second- largest drugmaker, needs more tests on weight-loss drug Acomplia to prove the company's claim that the medicine helps obese diabetics control blood sugar levels, researchers said.

A study in today's Lancet that suggests the drug may offer a new approach in diabetes treatment isn't conclusive, Naveed Sattar, a professor at the University of Glasgow, wrote in an accompanying comment. He said the improvement in blood sugar levels may have been caused by factors other than the drug. Sattar wasn't involved in the Sanofi-sponsored study of 1,047 overweight or obese people with type 2 diabetes.

``The results are encouraging, but they leave a number of key questions unanswered,'' Sattar said in a telephone interview. ``More studies are needed to assess the drug's true position in the treatment of diabetes.'' "

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