September 11, 2010
Diet Drugs To Face Scrutiny
Two weight-loss medicines will face tough US scrutiny next week as medical experts consider if the benefits of the drugs outweigh the potential side effects.
Arena Pharmaceuticals goes before an advisory panel on Thursday to see if its weight-loss pill, Lorqess, will get approval. The medicine is vital to Arena, as the small company has no approved drugs on the market.
The committee will first decide on Wednesday whether to recommend stricter action against Abbott Laboratories diet drug Meridia on concerns about heart problems.
The advice on both drugs will weigh heavily on the Food and Drug Administration, which will make the final call.
Drug manufacturers have failed to produce a truly effective pill for decades that help people shed a significant amount of weight without serious side effects.
When FDA advisors meet on Arena, "there's going to be a huge discussion on safety," predicts Hapoalim Securities analyst Jon LeCroy.
The FDA asked Arena to study what effects Lorqess might have on heart valves, a problem that led to the 1997 withdrawal of part of the "fen-phen" diet drug combination.
Lorqess, like fenfluramine, is designed to block appetite signals in the brain. But the Arena drug is more selective in the receptors it affects, and the company says studies have not found heart problems linked to the medicine.
The panel will be looking to see whether the company's data is strong enough to rule out a certain level of heart-valve damage, LeCroy said on Wednesday.
Arena faces a stricter safety bar because the drug "is not super effective," he added.
Like potential rivals, Lorqess is supposed to be used short term with diet and exercise. One year-long trial showed weight loss of 5.9 percent, compared with 2.8 percent with a placebo. But patients regaining weight once they stop using the drug is a concern.
"Being obese is a lifetime public health problem, and it isn't fixed by losing weight for six weeks, or a month or a year," consumer advocate Sidney Wolfe, head of Public Citizen's Health Research Group said recently.
The FDA's preliminary views on Lorqess should become public on Tuesday when the agency is scheduled to release documents prepared for the panel meeting.
Arena is expecting an FDA decision on Lorqess by October 22. Analyst LeCroy currently predicts approval of Lorqess in the second half of 2011 with sales approaching $600 million in 2015.
Meridia, which was approved for weight-loss use in 1997, has seen a drop in usage after data in November 2009 showed patients had more heart problems with the drug than with a placebo.
In January, Meridia drug maker Abbott halted sales in Europe after regulators said heart risks outweighed the benefits of the drug.
Although Meridia was never a huge seller, it took in $340 million worldwide in 2008. Analysts expect numbers to continue to fall with $101 million in global sales this year and $90 million by 2014, according to a consensus forecast by Thomson Reuters.
Consumer advocates and critics of Meridia have called for it's withdrawal for years, saying the slight weight loss is not worth the risk.
Abbott says the drug is safe but should not be used by people with heart problems.
A study called Scout showed that patients taking Meridia had a greater number of heart attacks and stroke than those given a placebo. Those who took the drug, only lost an average of 8.8 pounds.
In January, the FDA asked Abbott to add warnings against Meridia's use by heart disease patients and said it would ask an advisory panel if more action was needed. The FDA has not said what steps are being considered, but options could include more warnings on the drug or potential withdrawal from the market.
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