US and European orphan status for AbbVie’s glioblastoma candidate

4 August 2014
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Both the European Medicines Agency and the US Food and Drug Administration have granted orphan drug designation to US drugmaker AbbVie's (NYSE: ABBV) investigational compound ABT-414.

The product is an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme (GMB).

Glioblastoma multiforme is the most common and most aggressive type of malignant primary brain tumor. Each year in the USA and Europe, two to three out of every 100,000 people are diagnosed with glioblastoma multiforme, which has a five year survival rate of around 4%.

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