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Anavex Gets FDA Orphan Drug Status For ANAVEX 2-73 For Infantile Spasms Treatment


Anavex Life Sciences Corp. (NASDAQ: AVXL) revealed Tuesday that the Food and Drug Administration's Office of Orphan Product Development has granted Orphan Drug Designation to its ANAVEX 2-73 for infantile spasms treatment.

Anavex Life Sciences' VP of Regulatory Affairs, Kristina Capiak, commented, "Infantile spasms marks the second Orphan Drug Designation for our ANAVEX 2-73 program, following the Orphan Drug Designation received for the treatment of Rett syndrome.

The company indicated the regulator advances the evaluation of drugs that show promise for the safe treatment of rare diseases, defined as those affecting fewer than 200,000 people in the United States. The designation offered sponsors with development and commercial incentives. That included 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.

On Tuesday, the stock edged up by 2.9 percent.


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Posted-In: Biotech News FDA General

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