Lorcaserin, to be sold by Arena
as Belviq, aids those who suffer from obesity, who are overweight, and those who have weight related health conditions such as high blood pressure, high cholesterol and diabetes.
reported that Belviq works directly on the brain that regulates appetite, which the new drug affects the Serotonin 2C receptor of that part of the brain. The drug blocks appetite signals in the brain, and speeds up feeling of fullness with smaller meal portions.
In addition to Belviq intake, a combination of healthy diet and exercise activities improve weight loss of 5% or more of the initial weight.
According to BBC News UK
, Belviq has been approved for use in obese adults with a body mass index (BMI) of 30 or greater. However, the drug can also be used by overweight adults with a BMI of 27 or greater, especially if they have other weight related diseases such as high blood pressure, high cholesterol and type 2 diabetes mellitus.
Although Belviq was rejected back in 2010, concerning over tumors that developed in tested animals with the drug, Arena persisted to reapply. The pharmaceutical company resubmitted its application with additional data, finding little risk of tumors in humans using the drug by FDA's reevaluation.
In a report by USA Today
, director Janet Woodcock of FDA's Center for Drug Evaluation and Research stated, "Obesity threatens the overall well-being of patients and is a major public health concern."
"The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or overweight patients who have one other weight-related condition, such as high blood pressure, type 2 diabetes or high cholesterol," Woodcock further added.
also reported that FDA has set high standards when it comes to weight loss medications. Popular weight loss drugs in the past had safety issues. The so-called Fen-Phen
(Fenfluramine and Phentermine), a notorious weight loss drug combo during the 1990's, had to be pulled from the market in 1997 after being linked to damage in the heart valve. FDA said in a statement that Belviq did not appear to carry the same risks.
The FDA warned that Belviq is not for pregnant women, or those who are nursing. The drug may have adverse effects of depression, migraine, and disturbances in attention or memory. The drug's FDA-approved label says that it should not be used for more than 12 weeks if a 5% weight loss does not occur.
Belviq is expected to launch in 2013.