|Eisai And Arena Announce Publication Of Phase 3 Clinical Trial Analysis Of BELVIQ; EXACT Shares On The Move Following FDA Approval|
|By Marilyn Mullen|
|Friday, 10 October 2014 17:50|
Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that a pooled analysis of the BLOOM and BLOSSOM pivotal, Phase 3 clinical trials of BELVIQ® (lorcaserin HCl) was published in the October issue of Postgraduate Medicine, a peer-reviewed medical journal for physicians. In the pooled analysis, BELVIQ 10 mg twice daily, as compared to placebo and both in conjunction with diet and exercise, was associated with statistically significant weight loss and clinically relevant improvements in cardiometabolic parameters.
BELVIQ is a serotonin 2C receptor agonist approved in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke.
The BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trials were conducted in overweight and obese adults without diabetes. The pooled, modified-intent-to-treat results show that a statistically significantly greater number of patients taking BELVIQ lost greater than or equal to 5% and greater than or equal to 10% of body weight compared to placebo (47.1% vs. 22.6% and 22.4% vs. 8.7%, respectively) after one year of treatment. The mean percent weight loss for patients taking BELVIQ was also statistically significantly greater than placebo (-5.8% vs. -2.5%). Mean percent weight loss for those completing one year of treatment was -8.0% for BELVIQ and -3.7% for placebo, respectively. Echocardiograms were conducted on all patients as part of the primary safety endpoint of the trials. There was no apparent increased risk of cardiac valvulopathy associated with use in the combined dataset. The rates of FDA-defined valvulopathy were 2.3% and 2.2% for patients taking BELVIQ or placebo, respectively.
"The publication of this pooled analysis includes part of the dataset reviewed by the FDA in approving BELVIQ as the first new treatment for obesity in over a decade," said Gary Palmer, Chief Medical Officer, Global Neuroscience Business Unit at Eisai Inc. "This analysis provides evidence demonstrating the safety and efficacy profile of BELVIQ, and may be helpful to physicians as they consider pharmacotherapy for patients as part of their overall weight management plan."
Additionally, the data showed that after one year, there were statistically significant improvements in lipid parameters, including total cholesterol, triglyceride levels and HDL cholesterol. Changes in glycemic indicators demonstrated a decrease of 0.11% in HbA1c for BELVIQ treated patients compared to a decrease of 0.05% for placebo treated patients. Mean decreases in both systolic and diastolic blood pressure were also seen and statistically significant for BELVIQ versus placebo.
"We are facing an obesity epidemic in the United States, and it's important for physicians and patients to understand that when behavioral modifications alone are not enough to produce meaningful weight loss, effective pharmacotherapeutic options are available that can be added to a diet and exercise regimen," said William R. Shanahan, M.D., Executive Vice President and Chief Medical Officer of Arena Pharmaceuticals, Inc. "We know that weight loss can improve health parameters for patients who are obese or overweight with a related condition, and this pooled analysis further demonstrates that BELVIQ, in combination with diet and exercise, can be an effective intervention."
The most common adverse events in the pooled analysis included headache, upper respiratory tract infection and nasopharynigtis. Discontinuation rates for adverse events were 8.6% for patients taking BELVIQ and 6.8% for patients taking placebo, and the overall rates for serious adverse events were similar (2.7% and 2.3%, respectively).
Shares of EXACT Sciences Corporation (NASDAQ: EXAS) are up sharply Friday morning following the company’s announcement that its stool DNA test to detect colorectal cancer has been approved for coverage by the Centers for Medicare and Medicaid Services.
The company reports that, “the approval makes it the only FDA stool test covered by Medicare.”
Shares of EXACT closed Thursday at $18.12 and were recently trading at $24.44, up 34 percent.
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