Lorcaserin Re-Review Expected To Address Risk/Benefit Trade-offs, Rat Tumors
This article was originally published in The Pink Sheet Daily
Arena Pharmaceuticals gets new May 10 advisory committee review for its obesity therapy lorcaserin; execs say the recent positive review for competing Qnexa bodes well, and that this time around the risk/benefit profile for lorcaserin is much stronger.
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Lorcaserin Advisory Committee Will Again Be Weighed Down By Safety Concerns
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will revisit Arena’s obesity drug May 10; readjudication finds fewer cancers in rats than previously identified, but new data fails to rule out the 50% increased risk for valvulopathy sought by FDA.
Potential Cardiovascular Benefit Colors CV Safety Expectations For Obesity Drugs
Only a superiority trial could give certainty of CV safety for weight-loss medications prior to approval, FDA’s Robert Temple tells the Endocrinologic and Metabolic Drugs Advisory Committee.
Qnexa REMS Should Deter Off-Label Use Of Components, But Not Place Undue Burden
The Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving the combination of phentermine and topiramate for weight loss during its second review of Vivus’ application.