FDA Disapproves AstraZeneca’s Diabetes Drug Combination, Asks For More Clinical Data

The U.S. Food and Drug Administration (FDA) has rejected AstraZeneca PLC’s diabetes drug combination, the U.K. drugmaker said Friday. 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.

The health administration’s move came as a setback for AstraZeneca, which has been trying to secure a place in the drug market by bringing newer treatments. The drugmaker’s rivals such as Paris-based Sanofi, Denmark’s Novo Nordisk A/S and Indianapolis-based Eli Lilly & Co. are stepping up to bring in new treatments amid the growing diabetes pandemic, according to Bloomberg.

“The CRL states that more clinical data are required to support the application. This includes clinical trial data from ongoing or completed studies and may require information from new studies. AstraZeneca will work closely with the FDA to determine the appropriate next steps for the NDA and remains committed to the development of the saxagliptin/ dapagliflozin fixed-dose combination,” AstraZeneca said in a statement.

The company, however, said the FDA’s decision did not “affect ongoing interactions with other health authorities as part of these individual application procedures.” AstraZeneca’s shares fell 1 percent in early trading on Friday, underperforming a 1 percent rise in the European drugs sector, Reuters reported.

Last year, AstraZeneca estimated that the saxagliptin and dapagliflozin drug combination for type 2 diabetes could generate top annual sales of $3 billion, out of total diabetes revenue of $8 billion expected by 2023, according to Reuters.

Saxagliptin, which is marketed under Onglyza brand name, is part of a class of drugs called DPP-4 inhibitors. Under saxagliptin's treatment, the body produces more insulin, which in turn removes sugar from the blood. Dapagliflozin, sold as Farxiga in the U.S., is an SGLT-2 inhibitor, a drug type that blocks sugar from being absorbed into the kidneys. In this process, excess sugar is removed from the body through urine, controlling diabetes.