Unique Decision By EMEA Regarding Orlistat
Written by Stuart Stevens| Wednesday, 12 November 2008| There are 0 comments
The CHMP that advises the European Medicines Agency (EMEA) on whether medicine should be approved or not has given the OK for the weight loss medication Alli to be made available over the counter. This is an extremely important step as this is the only time that a medication has been re-classified from a prescription only drug to an OTC drug.
Alli which is a lower dose version of the weight loss medication Xenical will contain only 60mg of the active ingredient orlistat instead of the usual 120 mg found in Xenical. Alli will be in made available by pharmacists to men and women who have a Body Mass Index of 28 or above. The official classification for obesity is a BMI of 30+ and the official classification for being overweight is having a BMI of 25+.
Mr. John Clarke who is the President of GSK Consumer Healthcare said that the reclassification of orlistat was a confirmation of the "regulatory expertise" that the company had in the area of healthcare medications.
The Committee for Medicinal Products for Human Use gave their reasons for reclassifying orlistat as firstly, because clinical testing has shown that the 60mg version was safe and effective in helping overweight men and women lose weight when used alongside a low fat diet. Secondly, the side effects were milder than when using the full strength Xenical 120mg dose and thirdly that the accompanying literature with the Alli drug would enable people to make use of the medicine properly and safely.
The final approval for Alli to be made available over the counter is still up to the European Commission but it is extremely unlikely that they will reverse the recommendation of the CHMP. This means that by the end of the year 2008 GlaxoSmithKline should get the go ahead to launch the product in Europe. Alli has already been on sale in the US for some time now and has been generally well received by the general public.