The FDA is requiring the drug company to submit more clinical data.
AstraZeneca recently announced that they have received a Complete Response Letter (CRL) from the FDA in regards to their New Drug Application (NDA) for a combination of saxagliptin and dapagliflozin. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, and dapagliflozin is an SGLT2 inhibitor.
The FDA’s response requires AstraZeneca to show more clinical data about the safety and efficacy of this new combination product. The FDA may require AstraZeneca to submit data from new trials in addition to data from previous and ongoing studies. AstraZeneca has stated that the FDA’s response will likely not affect the individual drugs in the combination, saxagliptin and dapagliflozin, which are already on the market and have been FDA approved for treatment of type 2 diabetes.
AstraZeneca previously reported positive phase III trial data earlier this year. The company has stated it will continue to work closely with the FDA and other regulatory agencies to continue to pursue the approval of the new combination drug.
- The FDA has requested more clinical data from AstraZeneca regarding a new diabetes drug, a combination product with saxagliptin and dapagliflozin.
- The company may have to conduct new trials.
- Approval, marketing, and use of the individual components – saxagliptin and dapagliflozin – are unaffected by this decision.
AstraZeneca receives Complete Response Letter from US FDA for saxagliptin / dapagliflozin fixed-dose-combination. AstraZeneca website. Published October 16, 2015. Available at: https://www.astrazeneca.com/our-company/media-centre/press-releases/2015/astrazeneca-receives-complete-response-letter-from-us-16102015.html.