Onglyza…the Next Januvia?
On April 1st, diaTribe traveled to Washington DC to observe the regulatory discussions on a new diabetes drug that is waiting for approval in the US (it is also awaiting approval in Europe). The new drug, called saxagliptin, is a new kind of DPP-4 inhibitor, the same type, or class, of drug as Januvia. At the meeting, the FDA brought a panel of physician and research experts (called the Advisory Committee) to discuss the safety and efficacy of the drug and give recommendations about whether or not it should be approved. After a full day of sometimes-heated discussion, the panel voted overwhelmingly to recommend that the drug could be approved. The final decision is still in the hands of the FDA, but the agency almost always agrees with the panel in the end. That said, the FDA recently postponed its decision date by an additional three months, most likely for resource reasons. We think it would be great, with all the subsidies going on, if the FDA could get some funds to aid them in helping people with diabetes! Regardless, it seems likely that saxagliptin (which, if approved will be called Onglyza) will soon be available for your doctor to prescribe--so far it appears to be a safe drug with moderate efficacy that is very similar to Januvia.
