US Food and Drug Administration declines to approve type 2 diabetes drug from AstraZeneca

The US Food and Drug Administration (FDA) has delayed the launch of a new type 2 diabetes drug combination after refusing to approve it. AstraZenecan, the drug’s manufacturer, revealed that the FDA demanded more clinical data before the drug could be approved.
The drug, a combination of saxagliptin and dapagliflozi, is an important part of AstraZeneca’s plans. The company predicted an annual revenue of $3 billion from the drug.
The combination drug’s primary components, saxagliptin and dapagliflozi, are already approved for individual uses as a treatment for type 2 diabetes. The FDA’s refusal to approve the drug based on currently available clinical trial data is not expected to affect AstraZeneca’s sale of saxagliptin and dapagliflozin.
“This announcement does not affect ongoing interactions with other health authorities as part of these individual application procedures,” said AstraZeneca. “Based on the information available, the [complete response letter] is not expected to affect individual components of saxagliptin or dapagliflozi, which are approved for the treatment of adult patients with type 2 diabetes.”
Saxagliptin (marketed as Onglyza) is an oral diabetes medication that is used alongside diet and exercise to help control blood glucose levels. It is a daily diabetes drug, and a member of the drug class gliptins, or DPP-4 inhibitors.
DPP-4 inhibitors lower blood glucose levels by triggering a greater release of insulin in the pancreas and inhibiting the release of glucagon.
Dapagliflozin (marketed as Forxiga) is an SGLT2 inhibitor, which means that it assists the kidneys in their removal of glucose through urine. Forxiga is also linked to enhanced weight loss, but, being a relatively new drug, its long-term effects are unknown. Other SGLT2 inhibitors include Invoaka (canagliflozin) and Jardiance (Empagliflozin.)
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