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5th November, 2008
Sanofi-Aventis today announced that they have stopped research into Acomplia, so it is unlikely that it will be approved for use in the UK and Europe again. In addition, Pfizer, who were developing a slimming drug that also acts on canniboid receptors in the brain, have suspended their research into their drug. Merck, who were also developing a drug in the same family, called taranabant, have also suspended the development of this drug.
It is a shame that the canniboid receptors in the brain appear to be linked to more than just appetite, and that there is no longer the promise of another family of obesity drugs that health care professionals can use in the fight against obesity.
23rd October, 2008
Sanofi-Aventis have temporarily suspended sales of Acomplia in Europe, after the health authorities have decided that the risks of taking Acomplia are more important than the benefits. Sanofi-Aventis are also taking steps to suspend sales in non-EU countries.
The suspension has followed the results of a study carried out by the EMEA (European Medicines Agency), which showed that patients taking Acomplia had double the risk of developing psychiatric disorders of those taking a placebo. Also, i in another trial that took place between June and August 2008, there were five suicides in the group treated with Acomplia, compared to one suicide in the control.
Patients currently taking Acomplia should consult their doctor, but they do not need to stop taking the drug immediately.
The EMEA statement said:
"Patients who are currently taking Acomplia should consult their doctor or pharmacist at a convenient time to discuss their treatment.
"There is no need for patients to stop treatment with Acomplia immediately, but patients who wish to stop can do so at any time."
However, some doctors have expressed dismay at the decision. Many people have lost weight using the drug and have not developed the psychiatric side effects. One doctor stated that whilst he believed that patient safety should be the top priority, it was his understanding that if the patient treated neither had nor developed depression, you ruled out the issues with Acomplia.
Sanofi-Aventis are currently undertaking further trials of Rimonabant (Acomplia) and hope to have the suspension ultimately reversed.
8th May, 2008
Experiments in young mice have revealed that Acomplia may reduce the number of pathways that can be created in the developing brain. It is also known that blocking the Canniboid receptors in rats can also interfere with neural connectivity. Effects such as these may be associated with depression in humans.
9th April, 2008
Many Americans have been travelling abroad to obtain Acomplia, or buying the drug over the internet, as it is not currently licenced in the US.
5th March, 2008
The appeal court in Germany has confirmed the decision of the national health system not to reimburse the cost of Acomplia, claiming it to be a "lifestyle drug".
21st Aug, 2007
Acomplia has been predicted to become the first of a number of blockbuster Canniboid drugs that will be used for a variety of treatments, according to a report on Piribo.com.
The report states that canniboid drugs such as Acomplia, and others including Marion, Cesamet and Sative will be used to treat a wide variety of conditions, from weight loss to pain relief.
19th July, 2007
As expected, Sanofi Aventis has changed the labelling on Acomplia for the European Union market, to contraindicate it for patients with ongoing depressive illness, or for patients currently undergoing treatment for depression. This is because of the risk of psychiatric side effects.
These side effects have been known about, and doctors have been warned about them, since June 2006. It is just now that an upgrading of the warning has occurred following advice by the CHMP - the Committee for Medicinal Products for Human Use.
4th July, 2007
A research study, published in the July 2007 edition of "Hepatology, The Official Journal of the American Association for the Study of Liver Damage" has shown that Acomplia reduces the risk of liver damage in obese rats. Obesity in general causes many health problems, one of which is hepatic steatosis - a fatty liver. There are no other drug treatments for this condition. However, in a study where male obese rats received an oral dose of Acomplia daily for a duration of 8 weeks, treated rats had a reduced incidence of an enlarged liver and there were no incidences of hepatic steatosis. These results were more favourable than those of the control group, who recieved the same diet as the treated group but did not receive Acomplia.
20th June, 2007
German regulators have labelled Acomplia a "lifestyle" drug, meaning that state health insurance will not contribute to the cost of the drug. This means that the users of Acomplia will have to pay the full cost of the drug themselves.
18th June, 2007
Indian drug companies have launched a generic version of Acomplia.
14th June, 2007
The FDA advisory panel yesterday recommended that the FDA reject Acomplia. They were concerned about issues concerning the mental health of patients who take Acomplia, even though the drug has been approved for use in 37 countries outside the US. The FDA is not bound to follow the advice of its advisory panel, but it usually does.
However, given the decision in the US, it is likely that the EU licence for Acomplia will be reviewed. Sanofi-Aventis have stated that tests show that Acomplia brings about an increased incidence of "suicidal thoughts" and is not recommended for patients who are clinically depressed.
The European Medicines Agency (EMEA) are meeting on June 18th - 21st and will most likely discuss Acomplia, perhaps reinforcing warnings about dosing and contraindications. In theory, they could revoke the licence for the drug, but this would be an extreme move and is thought to be unlikely.
UPDATE: The EMEA are taking no action at present but will continue to review new clinical data on Acomplia, especially in patients who have psychological issues.
8th June, 2007
The FDA are set to release their review of Acomplia before a meeting scheduled for Wednesday 13th June, 2007, where independent experts will vote on whether or not the drug should receive regulatory approval. The FDA are not bound by the results of the vote, although it is likely that they will act upon it.
29th March, 2007
Sanofi-Aventis announced that Acomplia will be discussed by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee on June 13th. The meeting is likely to discuss safety concerns, as the drug's efficacy at promoting weight loss and improving blood lipid levels is well established. However, a Sanofi spokesman stated that the meeting would not "endanger" the FDA's approval, expected to be received on July 26th.
26th March, 2007
Sanofi-Aventis announced that Acomplia will be discussed by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee on June 13th. The meeting is likely to discuss safety concerns, as the drug's efficacy at promoting weight loss and improving blood lipid levels is well established. However, a Sanofi spokesman stated that the meeting would not "endanger" the FDA's approval, expected to be received on July 26th.
22nd March, 2007
The French government today authorised reimbursement by health insurance companies and state social security for Acomplia prescribed to patients who are obese and also have Type II diabetes, where other treatments have been insufficient. The social security system will reimburse 35% if the cost.
13th February, 2007
The approval of Acomplia by the FDA in the US has been delayed yet again. Sanofi Aventis said the FDA will take until July 27 to complete their analysis of the human data.
6th February, 2007
Acomplia has received a "favourable recommendation" to be reimbursed by health insurance and social security schemes in France when prescribed to obese, diabetic patients. It remains for the French Government to ratify this decision and state the proportion of the cost that will be refunded.
1st February, 2007
Acomplia may be the first drug of its class, but rival drugs that work in a similar way, by blocking hunger receptors in the brain, are fast on its heels. Merck is due to seek approval for its competing drug, currently called MK-0364, from the FDA during 2008, and both Pfizer and Bristol-Myers Squibb are currently testing apparently similar drugs. Meanwhile, Sanofi Aventis are still awaiting FDA approval for Acomplia.
15th January, 2007
In Germany the Ministry of Health has decided not to fund treatment with Acomplia, labelling it a "lifestyle drug" (see news article for 1st November, 2006 below), confirming the recommendation by the German Federal Joint Committee. Sanofi Aventis have argued that it should be covered, because it has other health benefits, including blood glucose control and beneficially altering the blood lipid profile.
The only European health authorities that have so far agreed that the drug should be funded by health insurance are Sweden, Denmark and Ireland. However, it is believed that the decision in Germany could have an impact on the other European countries where a decision has not yet been made, including the UK. Acomplia has yet to be reviewed in the UK by NICE.
Sanofi Aventis is to contest the ruling in Germany through the legal system. The company is presumably concerned that sales of Acomplia will not be as buoyant if it is not covered by health insurance.
Jan, 2007
Acomplia is to be known as Zimulti in the US
8th December, 2006
Sanofi Aventis, the manufacturers of Acomplia, have stated that they are hoping the FDA in the US will approve Acomplia around the end of April, 2007 or a little later. The company has stated that it resubmitted its application for approval of the drug in October, 2006 and the FDA now has all the data it requires.
6th December, 2006
Merck & Co, another pharmaceutical company, is also developing a slimming pill that works in a similar way to Acomplia. Clinical trials are currently taking place.
6th December, 2006
The results of a six month study using Acomplia to treat patients with type 2 diabetes have been revealed. The study was called SERENADE, standing for "Study Evaluating Rimonabant Efficacy in Drug Naive Diabetic Patients". The results from this study have reinforced previous findings that Acomplia significantly improves blood sugar levels and encourages weight loss.
In the treated group, Acomplia proved as effective as the current best diabetic drugs, whilst patients in addition lost an average of 15 pounds each. However, just under 10% of patients failed to complete the trial due to adverse side effects that have previously been reported, including nausea, depression, headaches and light headedness.
30th November, 2006
Pfizer today announced that two of its experimental obesity treatment drugs offer weight loss comparable to that seen by Acomplia. The first drug, currently called CP-945,598, induced a weight loss of between 4 and 5% in patients half way through the trial. This drug works in the same way as Acomplia, ie, it is a CB1 receptor antagonist.
Another Pfizer drug, currently called CP-346086, produced an average weight loss of 6% in trials. This drug works via a different mechanism - MTP inhibition. MTP stands for "Microsomal Triglyceride Transfer Protein" and it is a protein that affects lipid levels in the blood.
23rd November, 2006
Since the release of Acomplia in mid 2006, the regulators in Europe have received reports of psychiatric side effects in Acomplia patients, such as depression.
18th November, 2006
Rumours suggest that Acomplia is not likely to be approved by the FDA in the US until Spring 2007.
9th November, 2006
Acomplia has now been authorised for use in Mexico, and will be prescribed alongside diet and exercise to appropriate patients.
Well, it seems that it's not only the NHS in the UK that is looking for cost savings on drugs. In Germany, health experts and insurance companies are suggesting that Acomplia should be classified as a lifestyle drug (such as viagra) and not as a drug necessary for treating an illness.
There is mixed opinion in Germany about this. Many members of the medical profession feel that it is a shame not to be able to prescribe such an effective drug on purely cost grounds. However, economically it would cost a huge amount to the numbers of people who would qualify to receive it (those with a BMI in excess of 27). It has been argued that if the drug were just restricted to those with a BMI in excess of 35, the case for Acomplia being a medicine and not a lifestyle drug would be more likely to succeed, as it would be prescribed to far fewer people.
27th October, 2006
A one year trial of Acomplia published in The Lancet has shown the drug at a dose of 20mg statistically significantly:
The findings further indicate that the drug could be an important treatment for type 2 diabetes.