AbbVie's Investigational Compound Receives Orphan Drug Designation by Both the FDA and EMA

AbbVie (NYSE:ABBV) today announced the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme. Glioblastoma multiforme is the most common and most aggressive type of malignant primary brain tumor. Each year in the U.S. and Europe, two to three out of every 100,000 people are diagnosed with glioblastoma multiforme, which has a five year survival rate of approximately four percent.

"The orphan drug designation is an important regulatory advancement as we further our development in recurrent glioblastoma multiforme, a disease that is uniformly fatal with limited treatment options," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. "We are pleased to continue developing ABT-414 in Phase II trials in patients with glioblastoma multiforme based on the results of our Phase I program."

Results from the Phase I clinical program evaluating ABT-414 in patients with recurrent or unresectable glioblastoma multiforme were presented at the 50(th) American Society of Clinical Oncology (ASCO) meeting in Chicago earlier this year.

Source: The Wall Street Journal