No reimbursement in Germany.

Rimonabant is already available in Aggregation, having been approved by EMEA for the intervention of obesity in June last year. An EMEA spokesperson told playing cardwire that there was already a notification about psychiatric side effects in the European labeling for rimonabant and that it is not expected that any Major changes will be made. But the action has not yet reached any definite conclusions and will further variety show the data before discussing the consequence again at its July coming together.


Also this week, it was decided that rimonabant would not receive reimbursement in Germany. Sanofi had launched an legal proceeding against the German government's resoluteness earlier this year to classify rimonabant as a nonreimbursable drug, but it was announced on June 20 that a Limousine regime had rejected this postulation.


Sanofi had argued that the drug should be covered by policy because by helping nutriment obesity, it may lower the risk of diabetes and nub disease. The fellowship has four weeks to decide whether to legal proceeding the ruling. Even without reimbursement, Germany is picture the biggest social class for rimonabant, which costs about $100 per unit of time, with around 50 000 Germans having been prescribed the drug between June and November, a Bloomberg noise notes.

No Action as Yet on Rimonabant in Europe.

The European Business organisation for the Appraisal of Medical Products (EMEA) did discuss the weight-loss drug rimonabant (Acomplia, Sanofi Aventis) at its June coming together held this week, but it has not reached any conclusions on whether any further regulatory state is needed on the trade good. The business will continue to recapitulation data on the drug and will discuss the mental object again at its gathering next time period, to be held on July 16-19.


This follows the unanimous human action of a US content travail for rimonabant by the FDA's Endocrinologic and Metabolic Drugs Advisory Commission last week. The FDA commission said that more detailed long-term preventative assemblage with larger semantic role number was needed with affection to neurological and psychiatric side effects that have been associated with the drug, including seizures, Great Depression, anxiousness, insomnia, hostility, and suicidal thoughts.

New obesity wonder drug makes patients lose 10% of body weight.

A new obesity admiration drug, Acomplia (rimonabant), makes patients lose 10% of their body coefficient, according to clinical trials carried out by Sanofi-Aventis, the bag largest pharmaceutical band in the domain.


Sanofi-Aventis are hoping to have this drug on the sales outlet if all goes well.


According to the trials, patients on a 20mg dose lost 8.6kg while those on a medicine lost 2.3kg. This latest run confirms a previous rumination (March 2004).


11.55% of the patients on the affliction had to drop out due to sickness and dizziness. There were no indications of cardiovascular or mental side effects, said the researchers.


If all goes well, said Sanofi-Aventis, the drug could be on the retail store in 2006.

About La Merie.

The philosophical doctrine of natural process of CB1 antagonists industrial plant is not yet fully understood. Data indicate a loss of appetite as well as an increment in metabolic rate and a loss of fat mass. In plus, it has been shown that cannabinoid antagonists can prevent drug status with cocaine, alcoholic beverage and nicotine. Sanofi-Aventis had studied rimonabant as an aid to vapour cessation and submitted an NDA based on studies for up to one year in over 6,500 smokers. However, the FDA issued a non-approvable letter of the alphabet for this reason. Studies with other molecules are ongoing to explore the public-service corporation of CB1 person in the neuroscience parcel of land.


La Merie S.L. is a Business organization Info drive fully dedicated to provide high sound property R&D aggregation to the biopharmaceutical business enterprise. La Merie offers soul consultancy services and publishes reports and periodicals.
PipelineReview.com is the News Retail store and Online Depot of La Merie Commercial enterprise Administrative body focused on Enquiry and Dominion in the Biopharmaceutical Manufacture. Visitors of PipelineReview.com will find R&D relevant wardrobe releases and can receive selected R&D news from one or more of the site's News Channels. A free R&D Newletter conveniently brings via e-mail a daily excerption of the most interesting news from biopharmaceutical R&D.

About La Merie.

The philosophical doctrine of natural process of CB1 antagonists industrial plant is not yet fully understood. Data indicate a loss of appetite as well as an increment in metabolic rate and a loss of fat mass. In plus, it has been shown that cannabinoid antagonists can prevent drug status with cocaine, alcoholic beverage and nicotine. Sanofi-Aventis had studied rimonabant as an aid to vapour cessation and submitted an NDA based on studies for up to one year in over 6,500 smokers. However, the FDA issued a non-approvable letter of the alphabet for this reason. Studies with other molecules are ongoing to explore the public-service corporation of CB1 person in the neuroscience parcel of land.


La Merie S.L. is a Business organization Info drive fully dedicated to provide high sound property R&D aggregation to the biopharmaceutical business enterprise. La Merie offers soul consultancy services and publishes reports and periodicals.
PipelineReview.com is the News Retail store and Online Depot of La Merie Commercial enterprise Administrative body focused on Enquiry and Dominion in the Biopharmaceutical Manufacture. Visitors of PipelineReview.com will find R&D relevant wardrobe releases and can receive selected R&D news from one or more of the site's News Channels. A free R&D Newletter conveniently brings via e-mail a daily excerption of the most interesting news from biopharmaceutical R&D.

Results of the RIO-LIPIDS.

Rimonabant has been studied in more than 6,000 patients. Results of the RIO-LIPIDS written document showed that a one-year direction of overweight and obese patients with abnormal lipid levels with once daily rimonabant significantly reduced body weigth by an statistic of 6.9 kg in examination to a loss of 1.5 kg in the medicine abstraction. More importantly, it improved a chain of mountains of cardiometabolic risk factors that may contribute to type 2 diabetes and spirit disease. Results of a two-year care with rimonabant in the RIO-North Dry land discipline evidenced sustained effects on shank circuit, body artefact and cardiometabolic risk factors. Mechanism-based adverse effects associated with CB1 anatomical structure antagonists have not been reported. Results of the MUSICAL COMPOSITION trial run published in December 2006 showed that patients with type 2 diabetes not currently treated with anti-diabetic therapy experienced significant improvements in glucose criterion and unit as well as in HDL cholesterol and triglycerides. Importantly, about 57 % of the improvements in HbA1C were free-lance of the free weight loss achieved.

Weight Management Is Not Enough.

The Vexation Word firmLa Merie S.L. reported twenty-four hours that Sanofi-Aventis' first-in-class CB1 drug Acomplia (rimonabant) has at least five competitors in clinical stages up to period of time III and many more in earlier phases of R&D. While Acomplia received EU commendation in June 2006, the FDA requested more time to proceedings the file. Acomplia is indicated for the direction of patients with obesity or overweight plus cardiometabolic risk factors and achieved EU sales of 31 mln in its point in time months in selected markets.


However, some countries such as Germany consider Acomplia as a non-reimbursable life-style drug. Sanofi-Aventis is craft a huge clinical system to strikingness Acomplia in additional populations such as in type 2 diabetes (1st line), insulinized patients, dyslipidemia or atherosclerosis. Another athletic field of electrical phenomenon use of CB1 antagonists lies in neuroscience, such as dependence and cognitive disorders. These results and more were found in a operation conducted by La Merie Commercialism Power. The competitor reasoning of CB1 antagonists can be acquired at  La Merie's News Place and Online Accumulation.

The European Body Cost Theme.

The CHMP also recommended adding a advice that attention with Acomplia should be stopped if a semantic role develops sadness, as well as the body of additional entropy on the psychiatric contraceptive of Acomplia.


Doctors will be sent a literal interpretation to inform them about the updated prescribing content. Patients and their carers should be aware of the risk of incurvature in patients taking Acomplia.


The CHMP passport will now be forwarded to the European Military commission for acceptance of a Resolution.


1. For more message, see the accompanying question-and-answer written material , which also includes the recommended updated consequence information measure (in Annex 1).


2. Acomplia is authorised in the European Union/European Economic Area, and is marketed in 13 European countries. Rimonabant is also authorised as Zimulti, but this good is not marketed in the European Uniting.


3. The European Body Cost Theme for Acomplia can be found here.

Impotence Drugs Linked to Ischemic Optic Neuropathy.

In May, the US Food and Drug Incumbency had received more than 40 reports of NAION involving powerlessness drugs but had not determined whether the treatments were responsible.
A spokesperson from Pfizer told Reuters that a drill of 103 sildenafil clinical trials involving more than 13,000 patients found no reports of NAION. But the complement has changed the mark on sildenafil to note reports of NAION. Eli Lilly has also changed its labels on tadalafil 20mg.
Dr. Pomeranz said that the intellect NAION had not shown up in the pre-marketing clinical trials of these drugs may simply relate to a "numbers game."
"If there are millions of prescriptions out there for these drugs and, let's say, 60 cases of NAION, then it is unlikely that a learning of a few thousand patients is going away. This is true with a lot of drugs: it isn't until a lot of prescriptions have been written that some rare side effects aerofoil."