Poxel Gains Approval to Expand TWYMEEG Indication for Type 2 Diabetes with Renal Impairment in Japan
POXEL SA, a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announces that the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved the revision of TWYMEEG package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m2.
This approval follows positive topline results from the post-marketing clinical study TWINKLE (TWYMEEG in diabetic patients with renal impairment: A post-marketing long-term study) in Japanese type 2 diabetic patients with renal impairment, which confirmed TWYMEEG’s safety and tolerability profile, as announced last August. Based on these results, discussions with the Japanese regulatory authorities were initiated by Sumitomo Pharma, resulting in the approval that will be officially implemented by Sumitomo Pharma as of April 8, 2025.
“The approval of the revised TWYMEEG package insert from the regulatory authorities in Japan is a major milestone for Sumitomo Pharma allowing us to address a key patient population, particularly elderly individuals with renal impairment, who are faced with limited treatment options. TWYMEEG is an important asset in our existing diabetes franchise, and we remain fully committed to support its sales trajectory, building on the safety and tolerability profile observed from TWINKLE study”, stated Koichi Kozuki, Executive Officer, Corporate Regulatory Compliance & Quality Assurance Division, Senior Vice President, Head of Corporate Regulatory Compliance & Quality Assurance Division of Sumitomo Pharma.
“This regulatory achievement, combined with recent patent approvals, further strengthens TWYMEEG’s prescription strategy in a large patient population with high unmet medical need”, added Thomas Kuhn, Chief Executive Officer of Poxel. “Given the high prevalence of renal impairment among type-2 diabetic patients, this approval further strengthens the product’s commercial potential in other Asian territories.”
This milestone builds on the newly granted patent (n°7635474) by the Japanese Patent Office to Poxel covering the use of Imeglimin in type-2 diabetic patients with moderate to severe renal impairment until 2039, strengthening TWYMEEG’s patent portfolio in Japan and protecting its use in this population. Poxel previously received the grant of this patent in China, the world’s second largest type-2 diabetes market, further supporting ongoing discussions initiated by Poxel to develop Imeglimin beyond Japan.
