London
US health regulators have delayed their decision on whether to approve Sanofi-Aventis' highly anticipated weight loss drug, Acomplia.
The French company said the new action date by the US Food and Drug Administration for Acomplia, also known by the chemical name rimonabant, would now be July 27.
The company had initially expected to be able to begin selling the drug in the United States in the second quarter of 2006. But the FDA asked for additional information last year, pushing the expected approval decision date on the once daily pill to April of 2007 prior to last Monday's announcement of a further delay, Reuters report said.
It did not give any reason for the FDA's decision to extend the review period and an agency spokeswoman could not immediately be reached for comment.
Acomplia, for which Sanofi has forecast eventual annual sales of $3 billion assuming it wins US approval, has been on sale in Europe since last summer but has run into repeated snags with US regulators.
Sanofi has been tight-lipped about just what sort of information the FDA had requested and which it resubmitted on October 26. Industry analysts have been speculating that it involves concerns of possible side effects, including depression.
European health authorities cleared the drug for use along with diet and exercise in obese or overweight patients with associated health risks such as type 2 diabetes or abnormally high levels of fat in the blood.
Sanofi said it will now include data from a study to show the drug improves blood sugar control in patients with Type 2 diabetes in its application seeking US approval.
In addition to weight loss, Acomplia in clinical trials has demonstrated an ability to raise levels of HDL, or good cholesterol, lower blood fats known as triglycerides and reduce waist circumference.
But the clinical trials had a fairly high patient dropout rate due to adverse side effects such as dizziness, nausea, anxiety and depressed feelings.
Acomplia remains Sanofi's biggest new drug hope. Industry analysts polled by Reuters last week forecast the French drugmaker would this week report modest sales of 25 million euros in the fourth quarter of 2006 in those markets where it has so far been launched.
Source: http://www.tradearabia.com/tanews
Buy Xenical USA, Canada/ Buy Xenical UK Rest world
Buy Reductil UK Rest world
Buy Alli Diet Pill
Buy Hoodia Diet Pills
|
Acomplia
Menu 
