Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its proline, henagliflozin. The Category 1 drug is now approved for use in combination with retagliptin and metformin to treat adult patients with type 2 diabetes who have not achieved blood glucose standards despite metformin monotherapy.
Henagliflozin, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor, was initially approved to improve blood sugar control in patients with type 2 diabetes. The latest approval was supported by a multi-center, randomized, controlled, double-blinded Phase III study. The study’s results indicated that after a 24-week treatment period with a high-dose combination of henagliflozin with retagliptin and metformin (retagliptin 100mg/henagliflozin 10mg/metformin), there was a 1.54% reduction in glycated hemoglobin (HbA1c) from baseline. This triple-drug combination regimen demonstrated superior hypoglycemic efficacy, showing an additional HbA1c reduction of 0.52% to 0.65% compared to the corresponding two-drug combination regimen.- Flcube.com
