FDA rejects novel diabetes drug over safety fears

摘要

Last month, US regulators informed AstraZeneca and Bristol-Myers Squibb that they are not yet able to approve dapagliflozin, an oral antidiabetic drug on which the two companies are partnered. In a joint press release, AstraZeneca and Bristol-Myers Scfyibb disclosed that the US Food and Drug Administration (FDA) had requested "additional clinical data to allow a better assessment of the benefit-risk profile". The companies reaffirmed their commitment to dapaglifozin, adding that it had already been the subject of 19 clinical trials in which over 5000 patients were treated with the drug. They promised to "work closely with the FDA to determine the appropriate next steps".