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Arena Pharmaceuticals' Diet Pill Approved for Sale in US

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The diet pill maker won market clearance on a second-try effort. Belviq will be the first new weight-loss drug to hit the US market in more than a decade.

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MINYANVILLE ORIGINAL Arena Pharmaceuticals (ARNA) won government approval to sell the first new weight-loss drug in the US in more than a decade.

The drug, branded Belviq, was cleared for sale by the Food and Drug Administration, which has been concerned about safety of diet pills. The Japanese drug company Eisai will sell Belviq under a license agreement, paying Arena a portion of the product's sales.

After being halted for the news, shares of Arena rose more than 32% to $11.70 in early afternoon trading Wednesday. The stock is up more than 500% this year.

In May, Arena won the backing of government advisers who said the drug's benefits for obese people outweighed risks of taking it. (See Diet Pill Maker Arena Pharmaceuticals Wins Backing of FDA Advisers.)

Arena and rivals Vivus (VVUS) and Orexigen Therapeutics (OREX) have spent the last couple of years arguing that their diet pills are needed to stem the epidemic of obesity in America. The rising number of overweight people is leading to a myriad of health problems, including heart disease and diabetes, these companies say.

Like Arena's drug, Vivus' diet pill Qnexa was backed by a panel of FDA advisers in February. The FDA delayed an approval decision on Qnexa until July 17, and the company said that the extra time was related to a risk evaluation related to potential market clearance for the drug. Orexigen is some ways away from potentially winning approval. The company says it thinks it will be able to compete even if both Arena and Vivus beat it to market with competing products. (See Diet Pill Maker Orexigen Sees Room for Three Rivals.)

Shares of Vivus rose 9% to $28.75 on Arena's news. The stock is up almost 200% this year. Orexigen jumped 28% to $5.22 and is up more than 220% in 2012.

Arena's bid to sell its diet drug was rejected by the FDA in 2010. Vivus' pill also was turned back by the agency that year and Orexigen's drug was rejected in early 2011. All of the drugs raised too many safety concerns, the agency said. The FDA has been cautious to approve new drugs after risks associated with weight-loss treatments in the past resulted in market withdrawals. Abbott Laboratories (ABT) withdrew diet pill Meridia in 2010 because of concerns about heart attack and strokes. The diet-drug cocktail fen phen was taken off the market in 1997 because of risk of heart valve damage. The maker of fen phen, American Home Products, was later renamed Wyeth and is now part of Pfizer (PFE).

There are a number of warnings and precautions on Belviq's label. The label recommends assessing the treatment within 12 weeks. If a patient hasn't lost at least 5% of body weight, it's recommended that the treatment be stopped. Arena and Eisai agreed to conduct studies on the cardiovascular risks of their diet drug. They also will conduct studies on the effectiveness and safety of treating obese children.

Arena will make and supply the drug to Eisai from a company factory in Switzerland.

Twitter: @brettchase

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