Thursday, December 12, 2013

AstraZeneca diabetes drug requires more testing

- Panel recommends for narrow application
- More evidence called before wider recommendation

Advisers to the US drugs regulator refused to back a wider application ofAstraZeneca 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.

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