Arena (ARNA) Gets FDA Ok for Potential Blockbuster Fat Pill
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For the first time in 13 years the FDA approved a weight-loss drug. On Wednesday Arena Pharmaceuticals' (Nasdaq: ARNA) Belviq got the nod to treat obese adults, or overweight adults that have at least one weight-related comorbid condition like high blood pressure, type 2 diabetes, or high cholesterol.
In studies, compared with placebo, treatment with Belviq for up to one year was associated with average weight loss ranging from 3 percent to 3.7 percent. For those without type 2 diabetes, 47 percent lost at least 5 percent of their body weight versus 23 percent with placebo. In those with type 2 diabetes, 38 percent of patients treated with Belviq lost at least 5 percent of their body weight, versus 16 percent treated with placebo.
Despite a 140 percent rise in shares of Arena since an FDA panel backed approval of the drug on May 10th, the stock jumped another 30 percent following the official FDA blessing this afternoon.
With 35.7 percent of U.S. adults obese, in addition to approximately 17 percent of children and adolescents aged 2—19, the market for the drug could be immense. Analysts at Jefferies sees sales of Belviq reaching $1.5 billion by 2020.
While Belviq was approved, it wasn't without some tough labeling. The label recommends that the drug be discontinued in patients who fail to lose 5 percent of their body weight after 12 weeks of treatment. Also, Belviq should not be used during pregnancy as it may cause serious side effects. It may also impact attention or memory. More common side effects include non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth, and constipation. For diabetic patients, common side effects are low blood sugar (hypoglycemia), headache, back pain, cough, and fatigue.
Due to past problems with weight-loss drugs fenfluramine (fen-phen) and dexfenfluramine, which were banned in 1997 after evidence emerged that they caused heart valve damage due to activation of the serotonin 2B receptor on heart tissue, Belviq was study for the same impact. The FDA said Belviq does not appear to activate the serotonin 2B receptor when used at the approved dose of 10 milligrams twice a day. However, Belviq has not been studied in patients with serious valvular heart disease.
In addition to the labeling, the FDA is requiring Arena to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attack and stroke.
Arena is not the only one looking to bring an obesity pill to the market. VIVUS Inc. (Nasdaq: VVUS) received FDA panel backing for its Qnexa in February and the FDA will review the drug in July. Orexigen Therapeutics, Inc. (Nasdaq: OREX) also has its own version of an obesity pill.
Arena shares closed up 29 percent, VIVUS shares closed up 7.4 percent and shares of Orexigen finished up more than 20 percent.
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In studies, compared with placebo, treatment with Belviq for up to one year was associated with average weight loss ranging from 3 percent to 3.7 percent. For those without type 2 diabetes, 47 percent lost at least 5 percent of their body weight versus 23 percent with placebo. In those with type 2 diabetes, 38 percent of patients treated with Belviq lost at least 5 percent of their body weight, versus 16 percent treated with placebo.
Despite a 140 percent rise in shares of Arena since an FDA panel backed approval of the drug on May 10th, the stock jumped another 30 percent following the official FDA blessing this afternoon.
With 35.7 percent of U.S. adults obese, in addition to approximately 17 percent of children and adolescents aged 2—19, the market for the drug could be immense. Analysts at Jefferies sees sales of Belviq reaching $1.5 billion by 2020.
While Belviq was approved, it wasn't without some tough labeling. The label recommends that the drug be discontinued in patients who fail to lose 5 percent of their body weight after 12 weeks of treatment. Also, Belviq should not be used during pregnancy as it may cause serious side effects. It may also impact attention or memory. More common side effects include non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth, and constipation. For diabetic patients, common side effects are low blood sugar (hypoglycemia), headache, back pain, cough, and fatigue.
Due to past problems with weight-loss drugs fenfluramine (fen-phen) and dexfenfluramine, which were banned in 1997 after evidence emerged that they caused heart valve damage due to activation of the serotonin 2B receptor on heart tissue, Belviq was study for the same impact. The FDA said Belviq does not appear to activate the serotonin 2B receptor when used at the approved dose of 10 milligrams twice a day. However, Belviq has not been studied in patients with serious valvular heart disease.
In addition to the labeling, the FDA is requiring Arena to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attack and stroke.
Arena is not the only one looking to bring an obesity pill to the market. VIVUS Inc. (Nasdaq: VVUS) received FDA panel backing for its Qnexa in February and the FDA will review the drug in July. Orexigen Therapeutics, Inc. (Nasdaq: OREX) also has its own version of an obesity pill.
Arena shares closed up 29 percent, VIVUS shares closed up 7.4 percent and shares of Orexigen finished up more than 20 percent.
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