Arena Pharmaceuticals Inc. (ARNA: Quote) said Wednesday the U.S. Food and Drug Administration has approved its obesity drug lorcaserin, making it the first new drug therapy in nearly ten years to treat the disorder that is assuming alarming proportions.
Following the news, shares of Arena, which had been temporarily halted, surged sharply to close at $11.39, up $2.54 or 28.7 percent, in regular trade.
Lorcaserin is approved by the FDA as an addition to a reduced-calorie diet and exercise to treat obesity. The FDA decision comes after its panel in May voted 18 to 4, recommending approval, while concluding the potential benefits of the drug outweighed potential risks.
Lorcaserin approval was based on trial results that showed the drug along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5 percent or more of body weight after one year and managing weight loss for up to two years.
Arena said the safety and efficacy of co-administration of lorcaserin with other weight-loss products and the drug's effect on cardiovascular morbidity and mortality have not been established. The company will need to conduct six post-marketing studies, including a long-term cardiovascular outcomes trial to assess the effect of lorcaserin on the risk for major cardiac events.
The most common adverse reactions for patients without diabetes treated with Belviq were headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common reactions were hypoglycemia, headache, back pain, cough, and fatigue.
Arena will manufacture lorcaserin from its facility in Switzerland, and Eisai Inc. will market and distribute the drug in the United States. The drug will be marketed under the name Belviq.
Lorcaserin is also under review in the European Union.
Eisai has exclusive rights to market Lorcaserin in most of North and South America, including the U.S., Canada, Mexico and Brazil, while Arena owns rights to Lorcaserin outside of North and South America, including the European Union and Asia.
The lorcaserin approval comes even as another anti-obesity drug, Qnexa, from Vivus Inc.(VVUS) awaits approval. A decision on the drug is set for July 17.
Drug makers find it tough to come out with safe and effective anti-obesity treatments and there are instances of approved diet drugs being recalled due heart damage risks. Some drug makers have also abandoned drugs that were in developmental stage due to adverse effects.
Currently, Roche's Xenical, a prescription anti-obesity drug, and GlaxoSmithKline plc's (GSK) Alli, are the two FDA-approved drugs for obesity in the market, which is virtually untapped.
According to market research firm Global Industry Analysts Inc., the global market for anti-obesity drugs is projected to reach $10.3 billion by the year 2017.
ARNA closed Wednesday at $11.39, up $2.54 or 28.70%, on a volume of over 89.0 million shares on the Nasdaq. In after hours, the stock dropped 0.61%. In the past year, the stock has traded in a range of $1.23 - 11.99.
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by RTT Staff Writer
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