Anavex's Lead Candidate Gets Orphan Drug Status Yet Again

Anavex Life Sciences Corp. (NASDAQ:AVXL) announced that the FDA has granted orphan drug status to its lead candidate ANAVEX 2-73 for the treatment of patients suffering from infantile spasms.

We note that the FDA usually grants orphan drug status to those candidates that are being developed for the treatment of rare diseases affecting less than 200,000 patients in the U.S. This status will allow ANAVEX 2-73 to enjoy seven years of market exclusivity in the U.S. upon approval. Moreover, Anavex will be eligible to receive certain development and commercial incentives including prioritized consultation with the FDA on clinical studies as well as exemptions from or reductions in regulatory fees.

We note that this is the second indication for which ANAVEX 2-73 has received orphan drug status. In the past, ANAVEX 2-73 was granted this status for the treatment of Rett syndrome.

As per information provided by the company in its press release, infantile spasms are estimated to affect approximately 2-3 per 10,000 live births.

Currently available treatments in the market for infantile spasms include Acthar Gel and Sabril.

Apart from infantile spasms, Anavex is evaluating ANAVEX 2-73 in a phase IIa study for the treatment of Alzheimer’s disease. Considering that there exists significant unmet medical need for treatments addressing Alzheimer’s disease, the successful development and approval of ANAVEX 2-73 will be a huge boost for the company. As per data provided by the Alzheimer’s Association, it is estimated that about 7.1 million Americans will be affected by Alzheimer’s disease by 2025.

Anavex is a Zacks Rank #2 (Buy) stock. Some other favorably ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Retrophin, Inc. (NASDAQ:RTRX) – both sporting a Zacks Rank #1 (Strong Buy) and Acorda Therapeutics, Inc. (NASDAQ:ACOR) – carrying a Zacks Rank #2 (Buy).


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