European regulators recently ordered Sanofi-Aventis to withdraw its weight-loss drug Acomplia across the Europe Union, sending a crippling blow to the French pharmaceutical group.
After reviewing data that suggests obese and overweight patients had twice the risk of developing psychiatric disorders such as depression, anxiety and aggression, than those on a placebo, The European Medicines Agency (EMEA) determined the benefits no longer outweighed the risks for the drug – generically known as rimonabant.
A U.S. advisory panel declined approval of the drug last year.
Acomplia was the first promising drug to tackle the growing epidemic of obesity, since Phen-Fen, a combination treatment prescribed more than six million times before it was recalled for deadly side effects in 1997.
The FDA discovered that the drug combination in Phen-Fen was responsible for an alarmingly high occurrence of heart valve defects and a deadly condition known as primary pulmonary hypertension (PPH).
PPH is a disease caused by narrowing of certain blood vessels in the heart and lungs. A statistically significant number of persons who took Phen-Fen also suffered from PPH (reportedly 1 in 25,000 who used Phen-Fen for more than 3 months).
Acomplia was the first of a class of drugs called selective cannabinoid receptor CB1 antagonists that work by blocking hunger signals in the brain, thereby suppressing the appetite. Earlier this month, Merck & Co. said its experimental treatment taranabant, in the same class of drugs, won't make it to market because it causes depression and irritability in users.
Marketed in 18 EU countries since 2006, Acomplia was to be used alongside diet and exercise and to treat obese or overweight patients has shown moderate effectiveness.
Between June and August of this year, five patients taking Acomplia as part of a clinical trial committed suicide. One person that was taking the placebo committed suicide.
The company said they would comply with the request to temporarily withdraw marketing the drug and added it will provide additional documents from the trials to assists with the re-evaluation of Acomplia. 700,000 people worldwide had used the drug. #