More Good News Coming About Diet Pill Acomplia (Rimonabant) as Diabetes Drug
While highly anticipated diet pill Acomplia (rimonabant) remains stalled at the U.S. Food and Drug Administration, with no early approval in sight, more positive news appears to be on the way about the drug's benefits in aiding glycemic control in newly diagnosed type 2 diabetes patients.
Results of the so-called Serenade trial (Study Evaluating Rimonabant Efficacy in Drug Naive Diabetic Patients), a six-month study which began in March 2005 with 281 participants, are scheduled to be presented next month at the 19th World Diabetes Congress in Cape Town, South Africa.
Judging by the coy manner in which Sanofi-Aventis executives responded to questions about the study when they briefed financial analysts on October 31st, the results certainly seem to have been encouraging.
The primary objective of this fairly small trial was to assess whether giving newly diagnosed type 2 diabetics Acomplia -- together with a reduction in caloric intake of 600 calories a day -- brought their blood glucose as measured by the HbA1C test under better control than reducing caloric intake alone.
"This is a key study . . . The first study of treatment of patients suffering from type 2 diabetes," said Hanspeter Spek, Sanofi's head of pharmaceutical operations. "It will be presented at an international congress. We are looking forward to the presentation with a lot of optimism and confidence."
Pressed by analysts about the 99.99 percent probability that Sanofi already is well aware of the results of the study, Spek said: "It is good practice not to talk about the study until it is exposed to the professional audience and the public.
"Of course we are looking forward to this study with a lot of confidence," he repeated. "It is a landmark study."
So once again, the news from Sanofi's clinical trials of Acomplia appears to be extremely positive. If only Sanofi was equally forthcoming about what is holding up Acomplia at the FDA, we might be in a better position to assess the future of what may be a multi-faceted drug.
Saludos Cordiales
Dr. José Manuel Ferrer Guerra
Results of the so-called Serenade trial (Study Evaluating Rimonabant Efficacy in Drug Naive Diabetic Patients), a six-month study which began in March 2005 with 281 participants, are scheduled to be presented next month at the 19th World Diabetes Congress in Cape Town, South Africa.
Judging by the coy manner in which Sanofi-Aventis executives responded to questions about the study when they briefed financial analysts on October 31st, the results certainly seem to have been encouraging.
The primary objective of this fairly small trial was to assess whether giving newly diagnosed type 2 diabetics Acomplia -- together with a reduction in caloric intake of 600 calories a day -- brought their blood glucose as measured by the HbA1C test under better control than reducing caloric intake alone.
"This is a key study . . . The first study of treatment of patients suffering from type 2 diabetes," said Hanspeter Spek, Sanofi's head of pharmaceutical operations. "It will be presented at an international congress. We are looking forward to the presentation with a lot of optimism and confidence."
Pressed by analysts about the 99.99 percent probability that Sanofi already is well aware of the results of the study, Spek said: "It is good practice not to talk about the study until it is exposed to the professional audience and the public.
"Of course we are looking forward to this study with a lot of confidence," he repeated. "It is a landmark study."
So once again, the news from Sanofi's clinical trials of Acomplia appears to be extremely positive. If only Sanofi was equally forthcoming about what is holding up Acomplia at the FDA, we might be in a better position to assess the future of what may be a multi-faceted drug.
Saludos Cordiales
Dr. José Manuel Ferrer Guerra
posted by Klip7 at
4:14 PM
