There are no perfect drugs, just variations on good and bad. That's what investors in Human Genome Sciences (Nasdaq: HGSI) should be reminding themselves today after the Food and Drug Administration released documents for the advisory committee set to review the drug on Tuesday.
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 (Nasdaq: BIIB), BioMarin Pharmaceuticals (Nasdaq: BMRN), and Teva Pharmaceutical (Nasdaq: TEVA) all have drugs in the lupus graveyard.
With that in mind, the panel of experts is likely to be more lenient than the panels that reviewed Vivus' (Nasdaq: VVUS) Qnexa and Arena Pharmaceuticals' (Nasdaq: ARNA) lorcaserin. Obesity isn't nearly as debilitating as lupus. My guess is the panel will more likely mimic InterMune's (Nasdaq: ITMN) pirfenidone, where the panel shrugged off the fact that pirfenidone only passed one of its phase 3 trials. Benlysta's data package is much stronger than that, having passed two phase 3 trials.
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.
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