Arena’s BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) study for patients suffering from diabetes is now complete and the results are expected in late 2010. This study was a one-year, randomized, double-blind and placebo controlled Phase III trial on 604 patients with Diabetes Mellitus Type II who were overweight or obese and taking oral diabetes medications. These results will be filed as a Supplemental NDA (sNDA) after LORQESS (Lorcaserin) is approved. This study is of paramount importance for LORQESS to have an indication specific for the treatment or prevention of diabetes. Arena must clinically prove that taking LORQESS will improve HbA1c and Fasting Glucose to receive an indication for diabetes. If this proves to be the case, which was shown in BLOOM and BLOSSOM, then LORQESS could be covered by most Payers for the treatment of diabetes or the prevention of diabetes.
“Data from the 2007 National Diabetes Fact Sheet (the most recent year for which data is available)
Total: 23.6 million children and adults in the United States—7.8% of the population—have diabetes.
Diagnosed: 17.9 million people
Undiagnosed: 5.7 million people
Pre-diabetes: 57 million people
New Cases: 1.6 million new cases of diabetes are diagnosed in people aged 20 years and older each year.
Cost of Diabetes
$174 billion: Total costs of diagnosed diabetes in the United States in 2007
· $116 billion for direct medical costs
· $58 billion for indirect costs (disability, work loss, premature mortality)
See disclaimers in the side bar.
Disclosure: long ARNA shares.
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