FDA declines to approve AstraZeneca diabetes treatment

The FDA has said it will need more information before it can approve AstraZeneca’s combination diabetes therapy saxagliptin/dapagliflozin in a setback for the company. The FDA, in a complete response letter (CRL), told the company to provide more clinical data for the type 2 diabetes medication – a combination of saxagliptin and dapagliflozin drugs. This comprises clinical trial data from continuing or completed studies and may entail information from new studies. AstraZeneca has said that it will working closely with the FDA to determine what should be next steps for the NDA.

Commenting on the possible delay in the launch of the combination drug of saxagliptin and dapadliflozin, Deutsche Bank analyst Richard Parkes said that the decline by the USA health regulators suggests that there is a dirth of sufficient data on the new formulation. Patients treated with the combination achieved significantly greater reductions in HbA1c versus either agent alone plus metformin at 24 weeks, the company reported.

Saxagliptin, which is marketed under Onglyza brand name, is part of a class of drugs called DPP-4 inhibitors.

Saxagliptin, better known as Onglyza, is a drug that helps the body to produce more insulin, removing sugar from the blood.

Statistics say that about 382 million people suffer from diabetes, according to the global Diabetes Federation. The other component, Dapagliflozin, also known as Farxiga, blocks sugar from getting into the kidneys, helping to control diabetes. Type 2 diabetes tends to emerge later in life and is typically brought on by obesity and sedentary lifestyles. The adjusted mean change from baseline HbA1c of -1.47% in the saxagliptin/dapagliflozin combination group compared to -0.88% in the saxagliptin group and -1.20% in the dapagliflozin group.