Regulatory Focus™ > News Articles > US Regulators Approve First Obesity Drug in 13 Years

US Regulators Approve First Obesity Drug in 13 Years

Posted 28 June 2012 | By Alexander Gaffney, RAC 

In a possible shift its existing policy framework, the US Food and Drug Administration (FDA) has approved Arena Pharmaceuticals' anti-obesity drug Belviq (lorcaserin), making it the first anti-obesity drug to be approved in 13 years.

The drug was subject to concerns-as are many anti-obesity drugs-about cardiovascular risks to patients, and at least one public advocacy group had urged FDA not to approve the drug based on those concerns.

FDA seemed to take those risks into account in its decision on 27 June, saying it will require Arena Pharmaceuticals to conduct a total of six postmarketing studies to "assess the effect of Belviq on the risk for major adverse events such as heart attack and stroke."

Four of the studies to be conducted are pediatric studies, while the remaining two are intended to assess the effects of Belviq's toxicity and uncover any major cardiovascular events, respectively.

To assuage regulators, Arena had to conduct an 8,000-patient study on the cardiovascular risks of the drug. FDA noted there appeared to be "no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients."

The agency did urge caution for patients already suffering from cardiovascular disease, and the drug is contraindicated for pregnant women.

The drug is approved at a 10mg dosage level for adults with a body mass index (BMI) greater than 30, or greater than 27 with at least one weight-related condition.

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