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What: Shares of Aegerion Pharmaceuticals (NASDAQ:AEGR) are jumping 13%, its second straight day of big gains, following the release of briefing documents from the Food and Drug Administration's advisory panel regarding its lead drug candidate, lomitapide.
So what: As my Foolish colleague Brian Orelli mentioned about the advisory panel meeting later this week, the data being reviewed will be a mixed bag, but homozygous familial hypercholesterolemia, or HoFH, has largely unmet treatment needs at present, so approval could be likely. According to the FDA advisory panel's briefing documents, it's concerned about exposing lomitapide to a larger patient pool due to a larger risk-benefit profile having not been established yet. However, the panel seems to favor its appropriate use to a targeted patient population (i.e. life threatening illnesses and those with few therapeutic options).
Now what: Let's keep in mind that the FDA has no obligations to follow the advice of its advisory panel, but it's usually a good indicator, historically, which way the FDA will ultimately lean. With the actual advisory panel meeting slated for Wednesday, Aegerion shareholders now have a better idea what concerns the panel has regarding lomitapide and why approval could be likely. It's also worth noting that competitor Isis Pharmaceuticals (NASDAQ:IONS) which is developing a competing HoFH drug, mipomersen, with the aid of Sanofi (NYSE:SNY), has a meeting with the FDA panel just one day after Aegerion. This is definitely going to be a busy week for HoFH drug hopefuls.
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Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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