Thursday, June 14, 2007
Advisory Panel 14 - Zimulti 0
An FDA advisory panel of outside experts voted 14-to-0 that based on data provided to date, it was impossible to conclude that rimonabant has a "favorable risk-benefit profile," and recommended that Zimulti not be approved to aid weight loss by obese and overweight individuals.
If this was a baseball game (or even football game), that score adds up to a real bad day for Sanofi-Aventis.
A final decision is expected by July 27 by the FDA.
If this was a baseball game (or even football game), that score adds up to a real bad day for Sanofi-Aventis.
A final decision is expected by July 27 by the FDA.
Monday, June 11, 2007
Suicide a Potential Risk with Zimulti
The FDA has reported that patients who took Zimulti in clinical trials were more likely to report suicidal thoughts or actions than others who got a placebo, drug reviewers said in an analysis released Monday.
This comes one day before an advisory panel is scheduled to meet regarding the safety of the weight loss drug produced by Sanofi-Aventis, known as Acomplia in other parts of the world where it is being sold.
Food and Drug Administration staff also said the 20-milligram dose of the drug, Zimulti, produced clinically significant weight loss.
This comes one day before an advisory panel is scheduled to meet regarding the safety of the weight loss drug produced by Sanofi-Aventis, known as Acomplia in other parts of the world where it is being sold.
Food and Drug Administration staff also said the 20-milligram dose of the drug, Zimulti, produced clinically significant weight loss.
Sunday, June 10, 2007
Maker of Zimulti Has A Big Week Ahead
On Tuesday, June 12th, the FDA will for the first time reveal its views on the long-delayed diet drug Zimulti (Acomplia to the rest of the world).
The next day (June 13th), the agency's Endocrinologic and Metabolic Drug Advisory Committee, a panel of outside experts, will air various concerns about Zimulti/Acomplia and its side-effects, and vote on whether to recommend FDA approval.
Zimulti is predicted to be a blockbuster drug once approved in the United States, with sales estimates as high as $5 Billion in annual sales.
As news comes in, we'll keep you posted.
The next day (June 13th), the agency's Endocrinologic and Metabolic Drug Advisory Committee, a panel of outside experts, will air various concerns about Zimulti/Acomplia and its side-effects, and vote on whether to recommend FDA approval.
Zimulti is predicted to be a blockbuster drug once approved in the United States, with sales estimates as high as $5 Billion in annual sales.
As news comes in, we'll keep you posted.
Monday, June 4, 2007
UAE Approves Rimonabant (Acomplia/Zimulti)
The United Arab Emirates (UAE) became the first country to launch Acomplia/Zimulti in the Middle East.
A recent survey found that 37 percent of the UAE population is now obese -- one of the highest obesity rates in the Middle East, according to Sanofi.
"Among people who are overweight or obese, it is those with excess fat around their abdomen who are at the greatest risk of developing an abnormal lipid profile, type 2 diabetes and ultimately heart disease," said Dr. Wael Al Mahmeed, Vice President of the Emirates Cardiac Society.
A recent survey found that 37 percent of the UAE population is now obese -- one of the highest obesity rates in the Middle East, according to Sanofi.
"Among people who are overweight or obese, it is those with excess fat around their abdomen who are at the greatest risk of developing an abnormal lipid profile, type 2 diabetes and ultimately heart disease," said Dr. Wael Al Mahmeed, Vice President of the Emirates Cardiac Society.
Labels: Acomplia, Weight Loss, Zimulti
Subscribe to Posts [Atom]
