US FDA approves first obesity drug in 13 years
By Kerry Sheridan, AFP
June 29, 2012, 2:41 am TWN
WASHINGTON--U.S. regulators on Wednesday approved the first drug to treat obesity in 13 years, a drug called lorcaserin, marketed as Belviq and made by Arena Pharmaceuticals.
The drug works to control the appetite through receptors in the brain and was approved as additional therapy for certain overweight and obese patients, combined with diet and exercise.
Trials showed the drug helped people lose an average of three to 3.7 percent of their body weight after a year when compared to a placebo, the U.S. Food and Drug Administration said.
It is approved for use in obese adults with a body mass index of 30 or greater, or overweight adults with a BMI of 27 or greater who have at least one other condition such as high blood pressure, type 2 diabetes, or high cholesterol.
Arena's stock opened the day at US$9 per share and jumped as high as 47 percent on news of the U.S. approval. The company said it is also seeking approval on the European market, but has no timeline yet for a decision.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, described obesity as "a major public health concern," and said the new drug offers a treatment option when used "responsibly in combination with a healthy diet and lifestyle."
However, the FDA warned that Belviq is not for women who are pregnant or nursing, and called for further long-term postmarketing studies on the drug's potential risks.
The label will also recommend that Belviq be discontinued in patients who fail to lose five percent of their body weight after 12 weeks of treatment.
"These patients are unlikely to achieve clinically meaningful weight loss with continued treatment," said the FDA statement.
Belviq activates the serotonin 2C receptor in the brain, and may cause serious side effects if taken in combination with certain medications for depression and migraine that increase serotonin levels or activate serotonin receptors.
"Belviq may also cause disturbances in attention or memory," said the FDA.
Common side-effects in patients without diabetes include headache, dizziness, fatigue, nausea, dry mouth, and constipation.
In diabetic patients, side effects may include low blood sugar, headache, back pain, cough, and fatigue.