Poxel has announced that the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved an update to the package insert for TWYMEEG®.
TWYMEEG® has been available in Japan since September 2021 through a partnership between Poxel and Sumitomo Pharma.
The recent regulatory progress and strengthened patent portfolio are expected to support further commercial development of the product across Asia.
TWYMEEG® is an oral treatment used for managing type 2 diabetes. It is the first drug in a novel class of tetrahydrotriazine-containing compounds and works through both pancreatic and extra-pancreatic mechanisms.
It helps lower blood glucose levels by stimulating insulin secretion in response to glucose and by improving glucose uptake and metabolism in the liver and muscles.
Its action on mitochondria may also help protect against vascular damage and support pancreatic β cell function.
The revision now includes use in type 2 diabetes patients with renal impairment, specifically those with an estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73m².
This regulatory update follows positive results from the TWINKLE post-marketing clinical study, which evaluated TWYMEEG® in Japanese patients with type 2 diabetes and renal impairment.
As a result, discussions between Sumitomo Pharma and Japanese authorities led to the approval, which will be implemented on 8 April 2025.
The recent approval strengthens the treatment’s potential to support elderly patients and others with limited therapeutic options due to kidney impairment.
It also builds on the recent grant of a Japanese patent (No. 7635474) that protects the use of Imeglimin in type 2 diabetes patients with moderate to severe renal impairment until 2039.
This patent was previously granted in China, a major market for diabetes treatments.