December 12, 2006
Sanofi-Aventis’ Acomplia shows benefits in Type 2 diabetes study
New data shows that Sanofi-Aventis’ developmental drug Acomplia (rimonabant) significantly improved blood sugar levels in trial patients with Type 2 diabetes, while also reducing body weight.
The new data comes from Sanofi-Aventis’ first non-obesity trial with Acomplia.
The results of the six month trial, dubbed “Serenade,” were presented at the International Diabetes Federation World Diabetes Congress in Cape Town, South Africa.
The trial showed that HbA1c blood sugar levels in patients on a once-daily 20 mg. Acomplia pill fell 0.8% from their baseline value of 7.9 %, as compared to a 0.3% in the placebo group.
More significantly, Sanofi said, patients with a blood sugar level of at least 8.5 % at the baseline saw their blood sugar level decrease 1.9% when taking Acomplia, compared with 0.7% in patients taking a placebo.
“It is extraordinary that in this last group—about 25% of the participants—rimonabant was as efficient as several of the best anti-diabetic treatments,” Sanofi’s head of international development, scientific and medical affairs told Reuters.
The trial data also showed that patient’s waist circumference shrank 6.1 cm. (2.4 in.) if they took Acomplia, compared to 2.4 cm. (0.9 in.) for those on placebo.
Sanofi’s chief medical officer Douglas Greene said in a conference call with reporters that the company was examining when it would submit the new data to health authorities but declined to speculate how and when it would affect the prescription label.
Acomplia is approved in several European countries for use with diet and exercise to treat people who are obese or overweight and who also have diabetes or high cholesterol. In Mexico, Acomplia may also be prescribed as a complement to other anti-diabetics to improve blood sugar.
US approval of Acomplia is expected sometime in early 2007.
Analysts predict US sales of the drug could eventually reach $3 billion-a-year mark.