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Anavex Gets Orphan Drug Status From FDA For ANAVEX 2-73 For Rett Syndrome Treatment


Anavex Life Sciences Corp. (NASDAQ: AVXL) disclosed Friday that the FDA in the United States has given Orphan Drug Designation to its ANAVEX 2-73 for the treatment of Rett syndrome. The company is a clinical-stage biopharmaceutical firm developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases.

Anavex President and CEO, Christopher Missling, reacted to the developments saying, "The Orphan Drug Designation marks the first U.S. movement for ANAVEX 2-73. Rett syndrome is a devastating disease occurring in early childhood and almost exclusively in girls. As there is currently no cure and limited treatment, Rett syndrome represents a clear unmet clinical need."

He continued, "The acknowledgement from the Agency for this orphan designation allows us to formally move forward with the planned human clinical study in this disease indication, thereby potentially expanding the reach for ANAVEX 2-73 in addition to Alzheimer's disease."

Anavex said the FDA's Office of Orphan Products Development advances the evaluation of drugs, which indicate promise for the safe treatment of rare diseases, defined as those affecting fewer than 200 thousand people in the United States. The company added that the current designation provided sponsors with development and commercial incentives, including seven years of market exclusivity in the U.S., prioritized consultation by FDA on clinical studies and certain exemptions from or reductions in regulatory fees.

In the pre-market on Friday, the stock traded 2.4 percent higher.


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Posted-In: Biotech News FDA General

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