For people with type 2 diabetes, choosing the right treatment option can be very difficult given the sheer number of diabetes drugs that are available. But patients in the US who want to try using a relatively new class of drug called a DPP-4 inhibitor have two options today: Januvia or Janumet (Januvia combined in one pill with metformin), both manufactured by Merck. This may change as other companies move their own DPP-4 inhibitors forward. [For a more in depth discussion about incretins and the DPP-4 inhibitor class, see Learning Curve in the latest issue of DiaTribe.]
Last month (January 4th, to be precise), Takeda Pharmaceuticals announced that it had filed a New Drug Application to the FDA for its DPP-4 inhibitor, called alogliptin. This is one of the final steps towards drug approval, and this means that alogliptin could become available to patients as early as the end of 2008. Another DPP-4 inhibitor called saxagliptin (in development by Bristol-Myers Squibb and AstraZeneca) may also be submitted to the FDA in the next few months.
What does all of this mean for patients? It’s hard to say really, given that FDA approval is no sure thing. Just take a look at Galvus, a DPP-4 inhibitor that was developed by Novartis. Although Novartis filed a New Drug Application for Galvus a few years ago, the FDA did not feel comfortable with the drug’s safety profile and has asked for additional safety data that could push the drug’s approval back to 2010 or beyond. The drug is now available in Europe and we’re very interested to hear how people like it there.
If both alogliptin and saxagliptin are approved by the FDA, patients will have three DPP-4 inhibitor options. All three are likely to be very similar in their ability to improve glucose control, however, because they all work in a very similar way. All three drugs block a protein called DPP-4, and although there are no head to head studies of the drugs (i.e., no studies that compare them directly), it seems that all of them block DPP-4 roughly by the same amount (by which we mean all three drugs block DPP-4 almost completely).
There may be some safety differences between the drugs, but this is very hard for us to speculate on without seeing all of the clinical data, which hasn’t yet been released. We hope to see some of this data at the ADA - the world’s biggest diabetes conference - that takes place in June this year right here in San Francisco. There hasn’t been an ADA for over a decade that we can remember where so much important phase 3 drug data was going to be released. Exciting times. Stay tuned...
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