advisers reject Arena diet drug

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Arena shares fell nearly 40 percent canada goose outlet reviews in after hours trading Thursday to $2.28. The shares had been halted in regular trading pending canada goose outlet orlando results of the advisory meeting. Food and Drug Administration issued documents raising safety concerns that included the rat tumors and memory loss.

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Canada Goose Jackets The advisory committee voted 9 5 that potential risks from long term use of Arena lorcaserin outweighed possible benefits from modest weight loss. Panelists said canada goose outlet montreal they were unsure if tumors in lab rats meant the drug would increase brain or breast cancers in people. Canada Goose Jackets

do think (lorcaserin) is promising, but there too much uncertainty canada goose outlet vip at this time, said Jessica Henderson, the panel consumer representative.

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canada goose uk black friday MORE STUDY The expert panel called on Thursday for more study of Arena lorcaserin in people with diabetes, high blood canada goose jacket outlet uk pressure and other health problems, to better reflect patients who would use the drug if it was approved. canada goose uk black friday

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uk canada goose outlet The probability of lorcaserin ever reaching the market is small, BMO Capital Markets analyst Jason Zhang said after the panel vote. uk canada goose outlet

buy canada goose jacket can run a large trial in a high risk group and see if that will show canada goose outlet store montreal similar efficacy but a better risk profile. That a little remote, Zhang said. obesity epidemic. marketing rights to lorcaserin. buy canada goose jacket

cheap canada goose uk just couldn get over that we didn have a broader population that was representative of people most likely to get this (drug), said Dr. Lamont Weide, an advisory panel member and chief of diabetes and endocrinology at the University of Missouri canada goose outlet ottawa in Kansas canada goose outlet online reviews City. cheap canada goose uk

canada goose uk shop Arena is studying lorcaserin in overweight and obese diabetics and said it expects results later this canada goose shop uk year. canada goose uk shop

Canada Goose sale The companies believe the drug has positive benefit risk canada goose outlet niagara falls profile and Arena work closely with the canada goose outlet authentic FDA on its review, Arena Chief Executive Jack Lief said in a statement handed to reporters canada goose outlet nyc shortly after the committee vote. Canada Goose sale

Canada Goose Outlet Consensus forecast data from Thomson Reuters showed analysts expected Arena drug could reach peak annual sales of $822 million if it reached the market. Canada Goose Outlet

Canada Goose Parka Drugmakers have failed for decades to produce a pill to help canada goose outlet jackets people shed a significant amount of weight without serious side effects. advisers agreed tougher action was needed on Abbott Laboratories Inc diet drug Meridia, but split on whether it should be banned. Canada Goose Parka

BLOCKING APPETITE Arena lorcaserin was designed to block appetite signals in the brain in a similar way to the now withdrawn fenfluramine in the fen phen diet drug cocktail. The Arena drug is more selective in the receptors it affects and the company says studies have not found any of the heart valve problems with lorcaserin that were linked to fenfluramine.

Arena also argued the findings of rat tumors did not apply to people because they resulted from high doses or biological mechanisms specific only to rodents. No increase in cancer cases was seen in people.

canada goose clearance sale Patients who took 10 milligrams of lorcaserin twice daily for a year lost about 5.8 percent of their body weight on average, FDA reviewers said. Placebo patients lost 2.5 percent canada goose clearance sale.