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U.S. FDA Grants Orphan Drug Designation to ANAVEX 3-71 for the Treatment of Frontotemporal Dementia

NEW YORK, April 08, 2016 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ANAVEX 3-71 for the treatment of Frontotemporal dementia (FTD).

Frontotemporal dementia describes a clinical syndrome associated with progressive shrinking of the frontal and temporal anterior lobes of the brain. It causes a decline in language and/or behavioral changes, which include inappropriate social conduct, lack of empathy, blunted emotions or agitation, neglect of personal hygiene and a decrease in energy and motivation. To date, no treatment has been shown to slow its progression and the prognosis for people with FTD is poor. FTD afflicts an estimated 50,000 to 60,000 patients in the United States and represents an estimated 10 to 20 percent of all dementia cases.

“We believe that Orphan Drug Designation for ANAVEX 3-71 for the treatment of Frontotemporal dementia is a significant achievement,” said Kristina M. Capiak, Vice President of Regulatory Affairs at Anavex.

FDA Orphan Drug Designation is evaluated for drugs from all classes that are intended for the treatment of rare diseases, defined as diseases affecting fewer than 200,000 people in the United States. The designation provides sponsors with development and commercial incentives, including seven years of...


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