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AstraZeneca Fails to Win FDA Backing for Diabetes Treatment

AstraZeneca Plc failed to win U.S. approval for a new diabetes treatment that combines two of its existing drugs after regulators asked for additional data that may require new clinical trials.

The drugmaker will work closely with the Food and Drug Administration to determine the next steps and remains committed to developing the combination of saxagliptin and dapagliflozin, London-based AstraZeneca said in a statement Friday. Following Thursday’s deadline for the agency to make a decision on an application seeking approval for the treatment, the FDA issued a so-called complete response letter, requesting further data.

The delay is the second setback in as many weeks for AstraZeneca in its push to bring more treatments to market. The company on Oct. 9 said it was temporarily halting two trials combining cancer drugs due to reports of lung disease. Meanwhile, rivals such as Paris-based Sanofi, Denmark’s Novo Nordisk A/S and Indianapolis-based Eli Lilly & Co. are racing to introduce new diabetes...


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