Sumitomo Pharma: to seek full approval with post-marketing study

Sumitomo Pharma: to seek full approval with post-marketing study

Sumitomo Pharma Co., Ltd. announced topline results from the post-marketing TWINKLE study evaluating TWYMEEG® (imeglimin hydrochloride) in Japanese type 2 diabetic patients with renal impairment. The open-label, uncontrolled trial involved 60 participants with estimated glomerular filtration rates (eGFR) between 15–45 mL/min/1.73 m² or less than 15 mL/min/1.73 m². The drug was administered at 500 mg twice-daily for moderate/severe renal impairment or 500 mg once-daily for end-stage renal disease, with safety and tolerability assessed over 52 weeks. Adverse events occurred in 68.3% of subjects, predominantly mild or moderate, while serious adverse events affected 16.7% of participants, none causally linked to the drug. Four subjects (6.7%) discontinued treatment due to adverse events. The profile aligned with prior clinical trials, supporting the drug's safety in this population.

Currently, TWYMEEG® is not recommended for patients with eGFR <45 mL/min/1.73 m². Sumitomo Pharma plans to engage regulatory authorities in fiscal 2024 to revise the package insert, potentially expanding the drug's approved use. TWYMEEG®, a first-in-class tetrahydrotriazine compound, is marketed in Japan since 2021 under a partnership with Poxel SA. It functions via mitochondrial mechanisms to improve glucose metabolism and insulin secretion, with potential vascular protective effects.

The study underscores Sumitomo Pharma's commitment to post-marketing safety surveillance, aligning with its global quality assurance framework to ensure product reliability and patient safety. Regulatory updates and label revisions could influence market access and revenue potential for TWYMEEG® in renal-impaired diabetic populations.