A new diabetes medicine has been approved to be marketed by the Food and Drug Administration. The drug dapagliflozin, the second of a new class of medications aimed to improve glycemic control in patients with Type 2 diabetes, can now be marketed in the U.S. The drug will be marketed under the name Farxiga.
Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, a drug that blocks the reabsorption of glucose by the kidney, increases the excretion of glucose in urine and lowers glucose levels in the blood per the Los Angeles Times.It will join, and likely in prescribed with, a wide range of diabetes medications already available including metformin, glimepiride, pioglitazone, sitagliptin, and insulin. Many patients that have Type 2 diabetes are at risk for medical complications such as cardiovascular disease and damage to peripheral nerves and small blood vessels. Exercise and existing diabetes drugs do not drop levels of circulating blood sugar enough.
Canagliflozin was the first in this class of medications to receive the FDA’s blessing last March. This new diabetes medicine, Dapagliflozin, will be the second to receive the FDA’s approval in this class of medication. Four more drugs in this new category are expected to go before the FDA in the upcoming years.
In clinical trials which lead to FDA approval, patients taking dapagliflozin showed more improvement in blood sugar control than those taking the placebo. It has not yet been proven whether the medication, or others that are similar, improves long-term outcomes for patients with Type 2 diabetes by reducing heart attacks and strokes. The FDA has asked that additional studies be conducted to demonstrate the drug’s ability to reduce such risks.
Dapagliflozin, does not appear to increase the risk of bladder cancer as well as other infections of the genital and urinary organs. Upon approving the new diabetes medicine, the FDA ordered Bristol-Myers Squibb and AstraZeneca to conduct post-marketing trials to look for an increase in bladder cancer, as well as studies in animals to see how dapagliflozin affects urine flow and growth of tumors.