Written by Stuart Stevens | Thursday, 09 March 2006
Sanofi-Aventis the drug manufacturer got good news and bad news with the American FDA giving approval for Acomplia as a diet pill but not as anti smoking drug. The regulators said there wasn't enough evidence that the drug made any substantial or significant difference to smokers ability to quit, but set out clear guidelines for the drug firm which outlined what must be done to get the full approval for rimonbant as a weight loss supplement. Sanofi-Aventis made clear their intentions to work along with the FDA until full approval was obtained.
The actual requirements that the FDA set out for the approval of Acomplia are not in the public domain but it is expected that further specific tests will be required to be done by Sanofi Aventis under FDA supervision, before the drug will be sold in the US. If approved Acomplia would be a massive boost for the profits of the company and to its future earnings potential.
Rimonabant or Acomplia works by blocking craving signals that go to the brain. Incidentally the it blocks the brain receptors that are activated when you get the "munchies" after smoking marijuana. Sanofi claimed that it could also help smokers as it blocked the same receptor system which was involved in tobacco dependence. Sanofi Aventis has projected sales of 3 billion dollars a year for Acomplia.
The WHO reckons that more than one billion people are overweight and three hundred million are obese in the world today. The drugs potential is underlined by the fact that a global obesity epidemic could threaten millions of people that have an increased chance of cardio disease, diabetes and cancer. The testing of Acomplia noted that patient who used Acomplia lost weight and had better levels of HDL cholesterol that in turn may prevent the risk of heart disease.
The placebo controlled tests showed big weight loss differences between those on Acomplia and those taking the placebo; in some cases by as much as 3 times. The side-effects like vomiting and general feeling sick however resulted in nearly one in 5 people having to discontinue the test compared with thirteen percent leaving who used the placebo.
