Late January 2012 will be a busy, busy time for the FDA, pharma and lunch caterers

As we mentioned earlier, January 28, 2012 is the FDA action date for both the new SGLT-2 agent, dapafligozin as well as exenatide once weekly.  A few days ago, Takeda announced that the FDA has given them an action date of January 25, 2012 for alogliptin and the FDC alogliptin/pioglitizone.

The FDC of an glucose dependent insulin stimulating agent of a DPP-IV paired with an insulin sensitizer is a physiologic combination.  Mix in the pending patent expiry for pioglitizone in 2012, it is a well played franchise extension maneuver.  It will be interesting to watch how Takeda prices the FDC, if they “give away” the pio portion, or do they ask for a premium over the current DPP-IVs.

It will be a very busy time for the FDA to move all of these agents through the process by end January.  Two agents (dapa & exenatide QW) have some distinct safety baggage, and this is Takeda’s second time down the aisle with the FDA for alogliptin.  Will anyone take a bet on if the FDA starts the year with a clean sweep of approvals, rejections, or a mixed bag?  See the poll for your predictions….

Is the DPP-IV battle shaping up to be “what combination can you develop?”  We have Juvisync (sitagliptin + statin), alogliptin+pioglitizone, and the other DPP-IV manufacturers have an arsenal of hypertension and cholesterol agents at their disposal.  Mix-in depression, erectile dysfunction, Alzheimer’s, we could be looking at a multitude of combination therapies with a DPP-IV for years. I’m no product development / toxicologist guy, and I am sure there are limitations, but I would assume that the relatively benign profile of DPP-IVs and now with years of patient experience, may lead it to be the backbone of multiple different combinations that address the various co-morbid conditions of diabetes.

Drop me a line, let’s discuss

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