GlaxoSmithKline receives approval for alli ® (orlistat 60 mg) as a prescription medicine indicated for the aid to weight loss in Europe.
GlaxoSmithKline (GSK) announced today that alli (orlistat 60 mg) has received the nod as a drug without a prescription by the Committee for Medicinal Products for Human Use (CHMP). After this step, the product will be proposed for final approval by the European Commission and could be granted marketing authorization in the coming months. If the authorization is granted, there would be the first treatment approved and clinically proven to aid weight loss available without prescription throughout Europe. The drug is indicated for adults older than 18 years with a BMI of 28 kg/m2 or higher.
Clinical trials show that there is used in combination with a hypocaloric diet and low in fat, can help people lose 50% more weight than just with diet 1. Therefore, if someone lost 2 kilograms through diet alone, alli can help you lose 3 kilograms. alli works in the digestive tract to prevent about 25% of the fats in food are absorbed and produce an increase in peso2. That is why there offers an added motivation to start a weight loss and low in fat and to change the lifestyle and thus help promote weight loss.
Manfred Scheske, president of GSK Consumer Healthcare said: "Receiving the nod for there is a significant milestone for medicine and for overweight people in Europe. This means we are one step closer to the first commercially available treatment to aid weight loss without a prescription approved in the EU. Approximately half of the adult population in Europe are overweight, of whom approximately one third is obese. It is a new clinically proven option that truly enhances the efforts to lose weight and that could mean a huge difference in the fight against obesity. "
there was launched in the U.S. in June 2007 as the only treatment to aid weight loss without prescription approved by the Food and Drugs Administration (FDA). In the USA, users have a comprehensive program of on-line assistance to help with their weight loss efforts and helps to acquire healthy eating patterns in the long term. alli works locally in the gastrointestinal tract by blocking the absorption of fat, so there is minimal absorption of the active ingredient into the torrent sanguíneo.2 alli does not suppress appetite and no effect on the heart or the cerebro.2
Manfred Scheske continued: "there is not a miracle pill, but it can help people lose more weight than lose it only with diet, feel better and have a better image of themselves. It is marketed in the U.S. for a year and has been tested by millions of people so far, helping to keep a balanced diet to achieve a sustainable weight loss. "
If authorization is granted marketing, GSK could circulate there in the 27 EU member countries.
alli is a registered trademark of the GlaxoSmithKline group of companies.
Sunday, February 15, 2009
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