Reuters (6/26, Kelly) reports that as
regulators prepare to rule on whether to approve Arena Pharmaceuticals' diet
pill lorcaserin on Wednesday, watchdog group Public Citizen has asked the US
Food and Drug Administration to reject the experimental drug, citing concerns
that it could pose a risk to heart valves. The group noted that doctors at an
FDA advisory meeting last month said evidence from clinical trials showed an
increased heart valve disease risk in patients who used lorcaserin. The panel
still voted to recommend the drug for approval by a vote of 18 to 4.
U-T San Diego (6/27) reports the FDA
"could delay its decision and require Arena to file more information about
Lorcaserin, which could become the first new weight loss drug of its kind
approved in the US in more than a decade. The agency is expected to review a
possible competing drug -- Vivus' Anexa, on July 17."
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