San Diego: Arena Pharmaceuticals Inc said on Tuesday it submitted an official response addressing safety concerns of US health regulators over the company`s experimental weight loss drug lorcaserin, and believes it will gain US approval.Lorcaserin, which is being developed in partnership with Japanese drugmaker Eisai Co Ltd, is one of three new potential obesity treatments rejected by the Food and Drug Administration over safety issues.New data included in Arena`s response to the FDA`s complete response letter is intended to alleviate agency concerns over cancerous tumors found in rats in two-year animal studies of lorcaserin."With these last group of experiments, which had to do with mammary tumors in female rats, we believe that we have addressed all of the issues that the FDA raised in the complete response letter," Christy Anderson, head of Arena`s lorcaserin development program, said in a telephone interview.However, the companies cautioned that "the FDA may analyze or weigh the data differently than Arena and Eisai."Arena expects that the FDA later this month will confirm acceptance of the official response and set a new action date for an approval decision, likely about six months from the time of submission.Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States with nearly a third of the population falling into the growing category. But the FDA has set a very high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them.
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