French pharmaceutical major Sanofi (NASDAQ: SNY) has announced that the National Medical Products Administration (NMPA) has approved its iGlarLixi (insulin glargine, lixisenatide) for use in adult patients with type 2 diabetes who have poor blood glucose control. This approval marks a significant step in expanding treatment options for patients struggling with blood sugar management.
Approval Based on Clinical Trial Results
The approval is based on the results of the randomized, open-label, positive-controlled, parallel Phase III LixiLan-O AP and LixiLan-L CN studies conducted in the Chinese population. These studies targeted patients with poor blood control using oral drugs and basal insulin, respectively. The results showed that iGlarLixi achieved greater reductions in HbA1c from baseline compared to insulin glargine (-1.9% vs. -1.4%, P < 0.0001) and lixisenatide (-1.9% vs. -0.9%, P < 0.0001). Approximately 80% of patients treated with iGlarLixi achieved the blood glucose standard, with stable blood glucose levels maintained throughout the day.
Global Phase III SoliMix Study Findings
The global Phase III SoliMix study further confirmed iGlarLixi’s efficacy in patients with poorly controlled blood glucose levels despite treatment with oral hypoglycemic drugs, basal insulin, or GLP-1 receptor agonists (daily or weekly preparations). The study showed that iGlarLixi was more effective in lowering HbA1c levels compared to basal insulin or GLP-1 receptor agonists alone, with a higher proportion of patients achieving the standard (HbA1c < 7%). Additionally, iGlarLixi did not increase the risk of hypoglycemia or weight gain compared to basal insulin and caused fewer gastrointestinal reactions due to its stepwise titration dosing. The daily administration of iGlarLixi also significantly improved patient compliance.
Market Landscape and Future Outlook
iGlarLixi was first approved in the US in 2016 under the trade name Soliqua and generated USD 184 million in sales in 2020. The approval in China positions Sanofi to expand its market reach in the region, addressing significant unmet needs in type 2 diabetes management. Competing products in the market include Novo Nordisk’s Xultophy (liraglutide, insulin degludec), which is also commercially available. With its proven efficacy and safety profile, iGlarLixi is poised to make a meaningful impact on patient outcomes in China and beyond.-Fineline Info & Tech
