AstraZeneca diabetes drug requires more testing

12th Dec 2013 07:12

- Panel recommends for narrow application- More evidence called before wider recommendationAdvisers to the US drugs regulator refused to back a wider application of AstraZeneca and Bristol-Myers Squibb's medicine metreleptin, but did recommend it for a narrower range of people. The US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended the drug for the treatment of patients with generalised lipodystrophy (LD), a rare disease where normal body fat is lost and replaced by fat in other more dangerous internal areas. Metreleptin, which is being has already received orphan designation from the FDA and the European Medicines Agency but needs to be recommended for broader application to be a commercial success. However, the panel voted 10-2 against a wider application in partial LD such as often seen in diabetes, and called for more evidence, despite the "impressive magnitude of change" seen in the trial.The FDA is not bound by the EMDAC's recommendation, but will take it into consideration when reviewing the Biologics Licence Application for metreleptin.AstraZeneca and BMS said they remained committed to pursuing metreleptin for treatment in patients with metabolic disorders associated with partial LD. "The companies acknowledge the committee's feedback and will continue to work with the FDA to identify the appropriate patients with partial LD who may benefit from metreleptin," the companies said in a statement.OH