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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