There are no perfect drugs, just variations on good and bad. That's what investors in Human Genome Sciences
Surprise, surprise. Benlysta isn't perfect. The documents pointed out some known issues: The drug's robust effect after one year doesn't seem to last, and there seem to be certain populations that benefit more than others. The documents also revealed new findings that patients treated with Benlysta had a small -- so small it's potentially meaningless -- increase in the rate of suicide attempts.
Will the issues be enough to derail the drug? I doubt it. Benlysta treats lupus, a disease that hasn't seen a drug developed specifically to treat it in 50 years. Not that drugmakers haven't tried; Biogen Idec
With that in mind, the panel of experts is likely to be more lenient than the panels that reviewed Vivus'
Of course, the FDA eventually rejected pirfenidone. The panel only gives a recommendation after all. But I didn't see anything in the briefing documents for the advisory panel that gave the impression that the FDA was predisposed to reject Benlysta. If the advisory panel gives it a thumbs-up on Tuesday, I think the agency will likely follow suit.
Jeremy Phillips lays out a case for his three favorite American stocks.