Novartis’ Vildagliptin (LAF237)
Novartis presented updated data on their DPP-IV inhibitor for Type 2 DM last week. The slides are hotlinked. Nice presentation for analysts; too bad the data kinda suck. Not that the findings weren’t expected; they were. I don’t know what Wall Street is saying about the drug, but it’s going to have a tough time getting on formulary in the US for monotherapy, probably being relegated to a secondary, or even tertiary role, behind metformin and TZDs, despite the apparently cleaner safety/tolerability profile. In Europe, it’s unlikely to be approved for use as monotherapy. This is because vildagliptin just doesn’t give the HbA1c reduction of these other drugs. Yes, it comes close, but close doesn’t count for much in the face of currently cheap generic met and met/sulf combo therapy. The insulin add-on data are suspect until the full study details are released. FDA is particularly picky about insulin add-on study design. Reductions in insulin dose don’t count towards approval, only HbA1c reduction does. So, it’s important to understand how the study was conducted with regards concomitant insulin administration. The company correctly sees that prevention of hard outcomes is the way to go with this class, but they’re well behind the TZDs in this regard (e.g. ADOPT), and muraglitazar will also be tested in outcomes prevention eventually. I like the fact it’s an oral drug compared with Byetta (exenatide), but otherwise, Byetta has the advantage of better potential efficacy and a direct MOA not subject to pleiotropism from the off-taregt effects. The forthcoming exenatide LAR will compete directly with vildagliptin. Overall, Novartis has a tough road ahead with this drug. It’s got some nice things going for it, and it’s a welcome addition to the armamentarium, but too much competition and price pressure to be optimistic about its sales potential.
