Novel Type 2 Diabetes Therapy Dapagliflozin Recommended for Approval in Europe

Earlier this month, an initial regulatory assessment committee recommended the novel type 2 diabetes therapy dapagliflozin (Forxiga) for approval in Europe. A final decision from the European Medicines Agency (the FDA equivalent in Europe) on whether to approve the drug is expected within three months. Dapagliflozin belongs to a class of drugs called SGLT-2 inhibitors, which lower blood glucose levels by disposing of excess blood glucose through the urine (for more information, please see new now next in diaTribe #35). If approved in Europe, dapagliflozin would become the first SGLT-2 inhibitor to receive approval anywhere in the world.

Dapagliflozin’s recommendation for European approval came as a surprise to some, as the FDA denied approval of the drug in January. While Bristol-Myers Squibb and AstraZeneca (the manufacturers of dapagliflozin) have not discussed in depth the reasons behind the FDA’s rejection, the agency is likely concerned over potential increased risks for bladder and breast cancer as well as the potential for liver damage (for more information, please see new now next in diaTribe #39). The committee that recommended the approval of dapagliflozin in Europe also noted some concerns about the drug’s safety, including cancer risk, but called for these concerns to be evaluated post-approval rather than pre-approval. In the US, the FDA has indicated that additional clinical trial data will be required before it will reconsider approving the drug, and we hope to hear further details from the companies shortly regarding their plans to address the FDA’s concerns. Still, we believe that dapagliflozin’s recommendation for European approval bodes well for its eventual approval in the US. –BK