Amarin Corporation plc (ADR) (AMRN), Antares Pharma Inc (ATRS): 3 FDA Decisions You Need to Watch in 2013

3. A Tivo for kidney cancer?
By the end of July, we’ll know if a “Tivo” for kidney cancer will become available. I’m referring to Tivopath, AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO)‘ proposed brand name for its drug tivozanib. The FDA accepted the NDA for tivozanib in November and set a final decision date of July 28 of this year.

Tivozanib targets treatment of an advanced form of kidney cancer that occurs in more than 250,000 new patients each year across the world. More than 100,000 people die from the disease each year. Unfortunately, the currently available therapies for advanced kidney cancer can be highly toxic and in many cases only provide less than a year of progression-free survival.

A late-stage clinical trial of tivozanib found that the drug produced fewer adverse effects and increased the median progression-free survival rate compared to Nexavar, which is co-marketed by Bayer and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) .However, the overall survival rate for patients taking tivozanib was slightly lower than Nexavar. Despite this disappointment, good news from the FDA could still be on the way. If tivozanib is ultimately approved, expect AVEO to generate solid sales.

Going fishing
Trying to predict what decisions the FDA will make can be tricky. My guess, though, is that all three companies will receive positive news. I recommend paying especially close attention to Amarin Corporation plc (ADR) (NASDAQ:AMRN)’s sNDA. The company already launched Vascepa — but without a partner. I would be surprised if there aren’t several larger organizations carefully following the sNDA process for the drug’s second indication. The right decision by the FDA could mean that a big player goes fishing for a fish oil drug.

The article 3 FDA Decisions You Need to Watch in 2013 originally appeared on Fool.com and is written by Keith Speights.

Fool contributor Keith Speights has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned.

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