London, 19 July 2007 Doc. Ref. EMEA 330598 2007 QUESTIONS AND ANSWERS ON THE SAFETY OF ACOMPLIA RIMONABANT ; As part of its continuous monitoring of medicines, the European Medicines Agency EMEA ; has reviewed the available information on the safety of ACOMPLIA rimonabant ; , particularly on the medicine's psychiatric safety. It has concluded that ACOMPLIA's benefits continue to outweigh its risks, but that patients with ongoing major depression or who are receiving antidepressant treatment should not be prescribed ACOMPLIA and that some of the warnings in the medicine's prescribing information should be strengthened. What is ACOMPLIA? ACOMPLIA is a medicine containing the active substance rimonabant. It is used together with diet and exercise to reduce weight in adult patients who are: obese very overweight ; with a body mass index BMI ; greater or equal to 30 kg m2, or, overweight BMI greater or equal to 27 kg and also have other risk factors, such as type 2 diabetes or dyslipidaemia abnormal levels of fat in their blood ; . The active substance in ACOMPLIA, rimonabant, is a cannabinoid receptor antagonist. It acts by blocking a specific type of receptor called cannabinoid type 1 CB1 ; receptors. These receptors are found in the nervous system and are part of the system that the body uses to control food intake. By blocking the receptors, rimonabant can help patients to reduce food intake and to lose weight. The receptors are also found in peripheral tissues including adipocytes fat cells ; . 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 product is not marketed in the European Union. Why has the EMEA reviewed the medicine? ACOMPLIA received a positive opinion from the EMEA's Committee for Medicinal Products for Human Use CHMP ; on 27 April 2006, and a marketing authorisation from the European Commission on 19 June 2006. During the approval procedure, the main safety issue identified with the medicine was psychiatric side effects, especially depression. The company that makes ACOMPLIA was requested to monitor these side effects. In June 2007, as part of its continuous monitoring of the safety of this medicine, the CHMP requested all available information on the psychiatric safety of ACOMPLIA from sanofi-aventis. The review of this information was finalised at the CHMP meeting of 16-19 July 2007. Which data has the CHMP reviewed? The review included information on the psychiatric safety of ACOMPLIA, focusing on cases of depression in patients taking the medicine, including suicidal ideation thoughts about committing suicide ; and suicide attempts. This information came both from the company's monitoring of the use of the medicine from its launch until 18 June 2007, and from five studies involving 781 patients taking ACOMPLIA, which have been completed since ACOMPLIA was granted marketing authorisation. What were the conclusions of the CHMP? The CHMP concluded that the benefits of ACOMPLIA continue to outweigh its risks, except in patients with ongoing major depression and or taking antidepressants.
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As efforts to curb HIV Aids prevalence in Uganda continue, a minister has called for increasing female controlled preventive measures. Ms Rukia Nakadama, the Minister of State for Gender said that more women were getting infected by HIV than their male counterparts. She said this calls for methods that can safeguard womenTMs health. "New and long-term prevention methods are needed, particularly methods that are within the realm of womenTMs control, " Ms Nakadama said on Friday. She was addressing delegates at the opening of the Commonwealth Partners Forum conference on gender and new preventive technologies at Speke Resort Munyonyo in Kampala. The conference was premised on the theme: "Investing in Gender Equity: Ensuring the Development of and Access to New Prevention Technologies". The conference was a build up to the Eighth Women Affairs Ministers Meeting scheduled for June 11-14. Downplaying the use of the male condom, Ms Nakadama said the contraceptive does not empower women sexually because they do not have control over its usage. "They [women] have no control over the condom and instead have to depend on the man to protect themselves, making them more vulnerable to HIV Aids, " Ms Nakadama said. She said this was a major cause of increasing HIV infections among married couples because the women cannot do anything to prevent it. She instead encouraged the use of New Preventive Technologies NPTs ; that favour women to protect themselves without having to depend on their male partners. Nakadama cited methods such as cervical barriers, microbicides and vaccines as those that can empower women. Dr Florence Mirembe, a gynaecologist from Makerere University's Medical School, told the delegates that microbicides are substances that can be applied topically before sexual intercourse to prevent HIV infection and other sexually transmitted infections. She said the microbicides include gels, creams, suppositories, foams, sponges and vaginal rings, for example, acomplia report.
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Israel during the Gulf War were also associated with increases in heart attacks. The acute stresses of intense physical activity and sexual intercourse have also been shown to act as triggers of heart attacks. Are the findings real? While consistency between findings from the Netherlands and England, as well as a plausible biological mechanism a stressrelated increase in various hormones provide some confidence that the effect is real, in epidemiology we require additional safeguards, owing to the limited control we can apply to human beings in free range conditions.The most important issue is that of confounding literally, mixing together where one factor the confounder ; that is In order to provide at least a partial test for other stress-related causes of heart attacks, hospital admissions for traffic injuries and self-harm were also analysed. Since psychological stress and upheaval increase the propensity to engage in unhealthy and risky behaviour, the increase in the incidence in heart attacks might have stemmed from binge drinking, smoking and other acts of distracted carelessness. The absence of an increase in these incidents suggests that the match did not inspire pervasive recklessness. Indeed, the very specific nature of all the effects we have identified increases the likelihood that our findings are real and that, sometimes, you can believe what you read in the papers. s and acyclovir, for example, drugs.
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Good news of the approvable letter for Acomlia in weight management was countered by non-approval for smoking cessation. We believe its efficacy has been established and the likely issues are safety and indication. Scomplia is sanofi-aventis's late-stage pipeline product being developed to treat obesity and to reduce the cardiometabolic risks associated with obesity. Axomplia was filed for approval in April 2005 and the FDA issued an approvable letter on Friday 17 Feb 2006. Following this outcome we review below the available data for Acomplia, including the latest RIOAMERICA study published in the Journal of the American Medical Association on 15 February 2006. We summarise as follows.
J. L. Leaney and A. Benians contributed equally to this work. Address for reprint requests and other correspondence: A. Tinker, Rm. 420, 4th Floor, BHF Laboratories and Dept. of Medicine, University College London, 5 University St., London WC1E 6JJ, UK E-mail: a.tinker ucl.ac ; . C182 and aldactone.
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5. Pfizer received approval in January to market the first inhaled insulin, Exubera. The powdered insulin, taken just before meals, is released into the mouth and lungs through an inhaler similar to the ones that asthma patients use. In studies of more than 2, 500 adults with either Type 1 or Type 2 diabetes, the needle-free insulin was as effective as short-acting insulin shots in controlling blood sugar levels. 6. Sanofi-Aventis' new weight-loss drug, Rimonabant, is the first to target the endocannabinoid system responsible for `the marijuana munchies'. Acompliq homes in on a network of cells in the brain, liver and fat tissue that regulates hunger by linking appetite to the body's reward and satisfaction response, reducing food cravings by deactivating cannabinoid receptors. In half a dozen clinical trials, the compound helped 6, 000 patients lose up to 10% of their body weight over a year and maintain that loss for another year. It also improved patients' cholesterol profiles. 7. Merck's cervical cancer vaccine, Gardasil, has demonstrated positive results from a clinical trial in which 755 healthy, sexually active women were injected with the shots three times over six months and none developed precancerous growths after four years. The vaccine, which protects against four types of human papillomavirus HPV ; , is being considered as part of the inoculation roster for children in the US but faces resistance from concerned religious and parent groups who fear it may encourage sex by promoting the idea that it is riskfree. 8. Researchers at Pfizer have developed the first in a new class of compounds that prevents the human immunodeficiency virus HIV ; from entering and infecting healthy cells. While current medications thwart HIV at the end of its reproductive cycle, Miraviroc targets the beginning of the disease process. Now in the final stage of clinical trials, it could become a significant roadblock in preventing HIV infections from progressing to full-blown AIDS and amlodipine.
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Thames Avenue Surgery, Rainham, Kent Bernard Fernando general practitioner Division of Primary Care, University of Nottingham, Nottingham NG7 2RD Boki S P Savelyich research associate Anthony J Avery professor of primary health care Division of Community Health Sciences: GP Section, University of Edinburgh Aziz Sheikh professor of primary care research & development PRIMIS, University of Nottingham Mike Bainbridge technical director Pete Horsfield clinical director Sheila Teasdale service director Correspondence to: Anthony J Avery tony.avery nottingham.ac.
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Several routine antenatal blood tests may be checked in the EPAU. Knowledge of Rh antibody status is not required for all women with threatened or actual miscarriage. For many women, the risk of Rh sensitisation is negligible. However, Rh status should be available promptly for certain groups, to allow appropriate administration of anti-D immunoglobulin in non-sensitised Rh negative women.23 The specific groups are highlighted in the recommendations for this section. Anti-D immunoglobulin should be given in any case where there is clinical doubt and when the uterus is evacuated either surgically or medically.
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Challenge 8 Legal Requirements Pertaining to Pharmacies Serving LTC Homes Legal requirements relating to pharmacy have developed over many years and generally work well. These rules however were developed in the context of retail type pharmacy and not non-hospital, institutionalized pharmacy as we see in the LTC environment. Yet retail pharmacy is dramatically different than LTC pharmacy in a myriad of ways. An example of legal requirements geared for the retail environment not being appropriate for LTC is in the and actonel.
While this report focuses exclusively on the European and US Food and Beverages sector we have asked a few analysts at JPMorgan to consider the implication of obesity for sectors they cover and the relevance of this issue in the context of their investment thesis. We have also added to the lists one or two companies that are not covered by JPMorgan, but whose activities are influenced by obesity. Pharmaceuticals & Obesity Several drugs have been approved for weight loss but so far with relatively limited commercial success. The most popular pharmacological approach to obesity came in the 1990s with the combination of two existing diet drugs fenfluramine and phentermine ; into a cocktail known as "fen-phen". Each of these drugs were approved for short term use only and had not been studied in combination. Unfortunately this combination, when used chronically, was found to cause heart valve disease and sometimes death. This episode underlined the importance of sideeffects in an area that is essentially treatable with lifestyle change and has left a highly cautious attitude amongst physicians and regulators. Nevertheless, this has not stopped the pharmaceutical industry from trying to develop new anti-obesity drugs. The two main options available today to treat obesity are Meridia Abbott ; and Xenical Roche GlaxoSmithKline ; . In our view, these drugs have modest commercial value for three reasons: 1. Side effects: Meridia can raise blood pressure and has been associated with depression. Xenical requires strict adherence to a low fat diet otherwise patients will suffer uncomfortable gastrointestinal side-effects. 2. Cost & reimbursement: Xenical costs around $80 for a one-month supply and is not covered by medical insurance plans unless a patient is severely obese. We believe coverage rates are between 15-30% in the US. 3. Modest efficacy: Currently approved weight loss drugs help patients to lose some weight over a 12-month period, typically an additional 6-10lbs over diet alone. This sort of weight loss is recognized as providing a meaningful health benefit but it is not a radical change in weight or appearance. It's our perception that patients expecting these drugs to offer an easy way to substantial weight loss are frequently disappointed with the outcome and as a result are likely to stop taking the pills. Sanofi-Aventis is developing a new type of weight loss drug that could be approved in the US in early 2006 according to management. This drug, Acomplia, works on a new drug target known as the cannabinoid receptor. Acompliaa doesn't offer a major step forward in weight loss - as with existing weight loss drugs Acomplia can help patient lose an additional 10lbs of weight over diet alone across a 12-month period. However Sanofi-Aventis has shown that Acomplia has additional benefits beyond simple weight loss alone, for instance the drug favourably improves patients cardiovascular risk profile by raising "good" cholesterol and lowering triglyceride levels. In addition the drug has substantial benefits in type II diabetics and improves blood glucose control. These extra effects are the key to Acomplia's commercial potential we expect the drug to be a multi-billion dollar revenue generator ; because the positive effects on cardiovascular risk factors make it look more like a typical medicine and less like a lifestyle obesity drug. We believe this is the key to improving physician acceptance and unlocking reimbursement.
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