• After Failures, EMA Calls for Overhaul of Existing Obesity Treatment Guidance

    A new concept paper released by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) seeks to establish an updated framework for anti-obesity and weight control drug products. In its 1 October concept paper, " Concept paper on the need for revision of the guideline of medical products used in weight control ," CHMP looks to a November 2007 guideline on weight control, noting that two weight control products have been pulled from the marke...
  • US Regulators Approve First Obesity Drug in 13 Years

    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...