Eisai, Arena complete patient enrollment in Belviq Camellia-TIMI 61 study

About 12,000 patients were enrolled at over 470 sites in eight countries.

The five-year study will evaluate the impact of long-term treatment with Belviq CIV on the occurrence of major adverse cardiovascular events and conversion to type 2 diabetes mellitus in obese and overweight patients with cardiovascular disease and/or several cardiovascular risk factors.

The study will address the post-marketing requirement from the US Food and Drug Administration (FDA) to evaluate the long-term cardiovascular safety of Belviq.

Primary efficacy endpoints of the study include the assessment of the effect of Belviq on cardiovascular event risk reduction and the conversion to type 2 diabetes mellitus among patients without diabetes at baseline.

Arena Pharmaceuticals interim CEO Harry Hixson said: "Data from this cardiovascular outcomes trial will provide a better understanding of the potential of long-term treatment with Belviq, and we look forward to the study results."

The FDA has recently accepted the new drug application for an extended release formulation of Belviq.

If approved, the extended release formulation will provide a chronic weight management treatment in a once-daily dosing option.

Belviq when used with diet and exercise, can help some overweight (body mass index (BMI) =27 kg/m²) adults with a weight-related medical problem, or obese (BMI =30 kg/m²) adults, lose weight and keep it off.