Approve the weight loss drug Lorcaserin on June 27th, 2012.

The Issue

With over 66% of Americans overweight and 34% chronically obese, we need to provide our doctors with a safe and tolerable weight loss medication that will allow a number of overweight people to lose 5% or greater of their weight.

Obesity is a chronic disease that cannot just be addressed by lifestyle modifications alone. Obesity is indirectly related to many other diseases like heart, cancer, kidney, liver, diabetes, etc. that shorten people's lives, that reduce their ability to work productively. In addition, obesity is a major driver of the ever increasing health care costs that the United States and other nations are facing.

Lorcaserin has been shown in three phase 3 studies to have reduced at least 5% or greater weight loss in 67% of the of the people who completed the phase 3 studies. 34% of people completing the study lost 10% or greater and the top 25% of responders lost 16.7% of their weight. Research has shown that obese people losing at least 5% or greater of their weight is very beneficial in improving their quality of life and health.

Along with proper diet and moderate exercise, the weight loss achieved can be greater. In addition Lorcaserin has been shown in a two year study that it helps ght people keep the weight off.  In the second year of the two year study called Bloom, over 67% maintained their weight loss.

In addition, in one of the phase 3 studies that only enrolled patients with Type 2 Diabetes, the patients that completed the full study had significant weight loss but just as important, these patients saw a reduction of HbA1c and fasting glucose levels. HbA1c dropped by almost one percent. Fasting glucose dropped by an average of -27%.  These reductions allow T2DM patients to maintain better control of this disease and in many cases, patients were able to reduce Type 2 Diabetes medication.

In addition to the weight loss, patients taking lorcaserin in the studies showed decreases in both blood pressure and heart rate. Cholesterol levels were also improved.

Arena Pharmaceuticals who developed Lorcaserin has a PDUFA date of June 27th, 2012. We are urging the FDA to approve Lorcaserin on that date so that millions of Americans along with their Doctor's will have a safe, effective medication to assist them in the fight against obesity.

This petition had 368 supporters

The Issue

With over 66% of Americans overweight and 34% chronically obese, we need to provide our doctors with a safe and tolerable weight loss medication that will allow a number of overweight people to lose 5% or greater of their weight.

Obesity is a chronic disease that cannot just be addressed by lifestyle modifications alone. Obesity is indirectly related to many other diseases like heart, cancer, kidney, liver, diabetes, etc. that shorten people's lives, that reduce their ability to work productively. In addition, obesity is a major driver of the ever increasing health care costs that the United States and other nations are facing.

Lorcaserin has been shown in three phase 3 studies to have reduced at least 5% or greater weight loss in 67% of the of the people who completed the phase 3 studies. 34% of people completing the study lost 10% or greater and the top 25% of responders lost 16.7% of their weight. Research has shown that obese people losing at least 5% or greater of their weight is very beneficial in improving their quality of life and health.

Along with proper diet and moderate exercise, the weight loss achieved can be greater. In addition Lorcaserin has been shown in a two year study that it helps ght people keep the weight off.  In the second year of the two year study called Bloom, over 67% maintained their weight loss.

In addition, in one of the phase 3 studies that only enrolled patients with Type 2 Diabetes, the patients that completed the full study had significant weight loss but just as important, these patients saw a reduction of HbA1c and fasting glucose levels. HbA1c dropped by almost one percent. Fasting glucose dropped by an average of -27%.  These reductions allow T2DM patients to maintain better control of this disease and in many cases, patients were able to reduce Type 2 Diabetes medication.

In addition to the weight loss, patients taking lorcaserin in the studies showed decreases in both blood pressure and heart rate. Cholesterol levels were also improved.

Arena Pharmaceuticals who developed Lorcaserin has a PDUFA date of June 27th, 2012. We are urging the FDA to approve Lorcaserin on that date so that millions of Americans along with their Doctor's will have a safe, effective medication to assist them in the fight against obesity.

The Decision Makers

janet.woodcock
janet.woodcock
CDER Division of Food and Drug Administration
Commissioner Margaret Hamburg, Food and Drug Administration
Commissioner Margaret Hamburg, Food and Drug Administration
Food and Drug Administration

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