Sanofi-Aventis’ much-maligned obesity drug Acomplia is showing considerable promise as a treatment for type 2 diabetes in patients who are not adequately controlled with insulin therapy.
The French drugmaker is presenting data at the American Diabetes Association meeting in San Francisco from the first trial of Acomplia (rimonabant) in patients with type 2 diabetes, called ARPEGGIO. They show that a 20mg dose improved HbA1c by 0.89% from the baseline value and by 0.64% over the control group.
The 11-month study, which involved diabetes patients who had been treated with insulin for an average of six years, also revealed that glucose control (a HbA1C reading of less than 7%) was three times more pronounced when rimonabant was added than insulin and lifestyle advice alone. However on the negative side, while fewer patients in the Acomplia group compared with the control arm experienced serious
adverse events (16.8% versus 19.3), anxiety was reported in 5% of the patients in the control arm versus 14% of those on rimonabant. Depression was 7.5% in the control group versus 14% and Sanofi noted that most of the patients had a medical history of depression.
Commenting on the figures, co-ordinating investigator Priscilla Hollander of Baylor University Medical Center in Dallas, said that the ARPEGGIO trial demonstrated that “there is still room for significant improvement in diabetic patients who despite several years of standard therapies including insulins, in addition to diet and exercise measures, are not well controlled”.
This represents good news at last for Acomplia which was once expected to be a blockbuster. However, the drug has been pilloried since a marketing application was pulled in the USA in June last year after it looked unlikely that approval would be granted because of the potential psychiatric side effects linked to the treatment. It remains on sale in Europe but last week Acomplia was back in the headlines after data compiled by UK regulators suggested that the treatment was linked to five deaths.
Sanofi will be hoping it has more luck in the diabetes indication for Acomplia, which belongs to a new class of drugs that block cannabinoid receptors in the brain. A worldwide filing is planned for next year.
The Acomplia data came out just as Sanofi confirmed reports saying that it planned to cut up to 800 sales jobs in France. The firm validated a story published in the French newspaper Les Echos that between 700 and 800 reps in France are to lose their jobs, equivalent to one-third of its field force there.
