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AstraZeneca Fails to Win FDA Backing for Diabetes Treatment

  • U.S. regulator may ask for new clinical trials before approval
  • Lilly's Glyxambi to have `clear run' in U.S., BI analyst says
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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.