Some Question FDA Panel’s Approval Nod for New Weight Loss Drug

Some Question FDA Panel’s Approval Nod for New Weight Loss DrugA U.S. Food & Drug Administration (FDA) panel’s backing of a new weight loss drug is being questioned. The drug, lorcaserin, received mixed approval from the agency’s outside advisers last Thursday.

The panel voted 18 for approval and four against, with one abstention, said The Atlantic. It seems that the majority felt that lorcaserin’s benefits outweighed its risks and that despite any risks, “new tools are needed to treat a major health problem.” Although the agency is not bound to follow panel recommendations, it typically does.

According to the panel, said CBS/AP, lorcaserin’s benefits “outweigh the potential risks when used long term” in those who are overweight and obese. If the drug does receive agency approval, lorcaserin will be the first prescription weight loss drug seen in the United States in over ten years. The agency set June 27 as its target for deciding on lorcaserin approval/rejection.

Lorcaserin is meant for people who are obese or for people who are overweight and have been diagnosed with at least one weight-related health problem, such as high blood pressure, said CBS/AP.

People taking lorcaserin lost about 5.8% of their body weight in one year, versus 2.5 % for those taking a placebo. This difference is less than the agency’s 5% standard for approval. Of those taking lorcaserin, 47% lost at least 5% of their body weight after one year vs. 24% of those on the placebo, meeting a second FDA approval standard.

The risks are worth noting, said The Atlantic. For instance, lorcaserin caused tumors in rats and caused heart valve damage, an issue seen with the now banned drug, Fen-Phen. CBS/AP noted that issues with increased risks of high blood pressure in diabetics or heart valve damage, which can be life-threatening, have been seen in prior weight-loss pills.

Lorcaserin is one of three experimental weight-loss drugs presented to the FDA for approval for the second time. The FDA rejected all three over serious potential side effects, said CBS/AP, and asked for additional information on safety risks, including the possibility of birth defects linked to Qnexa. Vivus Inc. just received FDA panel endorsement on Qnexa.

Meanwhile, we recently wrote that FDA advisors backed heart studies for obesity drugs, including Qnexa and lorcaserin, by Arena. According to a prior Reuters report, U.S. drug advisers suggested that heart safety studies be required for new obesity drugs sold in the U.S. even if clinical trials do not initially show evidence of increased heart risk. “Anti-obesity drugs have a bad track record of cardiovascular risk,” said

Dr. Marvin Konstam, a professor at Tufts University School of Medicine and panel member, wrote Reuters.
The panelists also suggested that patients at increased risk for cardiac disease, such as the elderly, be enrolled heart disease in trials. According to Reuters, the advice is very similar to FDA guidance issued to

Type 2 diabetes drug makers. That guidance mandates companies to prove the medications do not increase risks for heart attacks and heart problems.

Arena’s new diet drug application for lorcaserin was recently accepted by European regulators.

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