AstraZeneca says the US Food and Drug Administration (FDA) wants more clinical data on its dapagliflozin treatment for type 2 diabetes in adults.
Astra is developing the therapy with US firm Bristol-Myers Squibb and says it has already conducted 19 clinical trials with 8000 adults.
The FDA, however, wants more data to assess the "benefit-risk" profile of the drug, which Astra says "includes clinical trial data from ongoing studies and may require information from new clinical trials."
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AstraZeneca and Bristol-Myers Squibb say they "remain committed to dapagliflozin" and will work with the FDA to provide the data.
AstraZeneca shares have outperformed the FTSE 100 over the last 12 months, gaining 4% against a loss of 5% for the index overall.
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