Approval for AstraZeneca and Bristol-Myers Squibb’s diabetes drug dapagliflozin has been rejected by the US Food and Drug Administration.
The FDA issued the rejection in its complete response letter, stating that additional clinical data is needed to better assess the benefits and safety of the investigational compound. The regulator said it may also need information from new clinical trials to determine the appropriate next steps for the drug application.
In a joint statement, AstraZeneca and Bristol-Myers Squibb said they remain committed to the drug’s development, stating, “This commitment is based on the benefit-risk profile of this investigational medicine, from a clinical development programme that included more than 8,000 adult patients with type 2 diabetes in 19 clinical trials.”
Dapagliflozin is being investigated to evaluate its safety and efficacy in improving glycemic control in adults with type 2 diabetes, for use as a monotherapy and in combination with other anti-diabetic agents.