Matthew Mintz
As reported in the Wall Street Journal, the US FDA did not approve Astra Zenca and Bristol Myers Squib's pending drug dapagliflozin. According to the report, the companies stated that the FDA has requested additional clinical data "to allow for a better assessment of the benefit-risk profile for dapagliflozin." When the FDA requests "additional clinical data" this usually means there are unresolved safety concerns. It also means there will certainly be a delay, as well as the possibility the drug never gets approved. Concerns are likely due to higher than expected rates of breast and bladder cancer, as this was seen in some of the orginal studies submitted to the FDA. Back in July, the FDA advisory panel voted against approving this drug, mainly for these safety concerns as well as some additional safety concerns regarding liver toxicity.
This is a major disappointment, as dapagliflozin was a novel diabetes agent. It works by blocking SGLT2, which is important in the kidney's ability to reabsorb blood sugar. SGLT2 inhibitors like dapa prevent sugar reabsorption, and thus promote sugar excretion from the kidney. Thus, diabetics taking this med literally lose sugar. Though the efficacy of dapa is similar to the last generation of new drugs (TZD's, DPP4's), a significant side benefit is 1) by losing sugar you are losing calories and thus these medications promote weight loss and 2) when you lose sugar through the kidneys, you also lose fluid, which means dapa also works as a diuretic and can lower blood pressure.
Thus, as a diabetes pill that not only lowers blood sugar but also promotes weight loss and lower blood pressure, dapa and SGLT2 inhibitors are significant breakthroughs, making their delay all the more painful.
Source:http://boards.medscape.com/forums?128@96.Sz52ac2weTw@.2a2e9c87!comment=1
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