21 May 2020
Posted in Pharma
Label update to encourage prescription of anti-diabetic drugs outside the SGLT-2 inhibitor class
Following the FDA’s safety review on sodium glucose-transporter-2 (SGLT-2) inhibitors, a label update was issued stating that patients undergoing any scheduled surgery should discontinue treatment up to 3-4 days in advance of surgery. This label update is expected to influence physician decisions, encouraging the prescription of anti-diabetic drugs outside the SGLT-2 inhibitor class, according to GlobalData, a leading data and analytics company.
Akash Patel, Pharma Analyst at GlobalData, comments: “Safety issues remain a concern around the profile of SGLT-2 inhibitors, including those identified in the FDA review. SGLT-2 inhibitors can increase the risk of diabetic ketoacidosis (DKA), particularly in the case for patients undergoing surgery. Furthermore, the SGLT-2 inhibitor class of T2D drugs are associated with several side effects that vary between each inhibitor, such as urinary tract infections and genital mycotic infections. These issues will continue to be a threat to the further growth of these drugs’ market share within the diabetes space.”
SGLT-2 inhibitors have recently had several label updates for Type 1 Diabetes (T1D), with approvals for Farxiga in the EU and Japan, Suglat in Japan and Zynquista in the EU. In the US, however, similar FDA approval has been challenging with the FDA rejecting applications for both the Farxiga and Zynquista label updates to include T1D patents, with these decisions due in part to the increased risk of DKA in patients taking these treatments.
Akash adds: “GlobalData expects that the label update will encourage the prescription of anti-diabetic drugs outside the SGLT-2 inhibitor class for some diabetic patients, while the drug class is anticipated to continue facing difficulties gaining FDA approval for treating T1D patients due to their poor safety profile.”