Daiichi Sankyo's Innovative Drug Tarlige (Mirogabalin Tosylate) Approved in China for Diabetic Peripheral Neuropathic Pain

China Finance Online, July 5th: Daiichi Sankyo (China) recently announced that its self-developed innovative drug Delijing (Mirogabalin Besylate Tablets, TARLIGE) has been approved by the National Medical Products Administration for the treatment of diabetic peripheral neuropathic pain in adults.

"Daiichi Sankyo is committed to the research, development, and breakthrough of third-generation calcium channel modulator technology. The original product, mirogabalin besylate, has been on the market in Japan for five years. Its recent approval in China will address the longstanding treatment challenge of having no effective medication for diabetic peripheral neuropathic pain in the country," said Tsunehiko Ogata, General Manager of the Development Headquarters at Daiichi Sankyo (China). He added that, going forward, the company will continue to leverage its self-developed innovation capabilities to comprehensively achieve global synchronized R&D of new drugs, further accelerate the launch of multiple innovative drugs in China, and bring effective treatments and methods to Chinese patients as quickly as possible.

This approval is based on the results of the DS5565-A-A315 clinical study, a randomized, double-blind, placebo-controlled Phase III clinical trial in China. The trial included 393 subjects and aimed to evaluate the efficacy and safety of mirogabalin besylate in treating patients with DPNP. The study results showed that, compared with the placebo group, the group receiving 15 mg of mirogabalin twice daily demonstrated a statistically significant improvement in pain scores at week 14 (P=0.0301), along with notable improvements in the patients' overall impression of pain, sleep, and quality of life.

In addition, a pivotal Phase III clinical study (DS5565-A-J303) of mirogabalin besylate in Asian patients with DPNP showed that the improvement in pain scores at week 14 was significantly different for the group receiving 15 mg of mirogabalin twice daily compared to the placebo group (P=0.0027). In the subsequent 52-week open-label extension study, out of 214 participants, 169 completed the 52-week study; the mean pain intensity decreased from 42.1 mm to 31.1 mm compared to baseline. Furthermore, a Phase III study of 14 weeks duration involving patients with renal impairment (30 with moderate and 5 with severe impairment) also demonstrated the favorable safety and tolerability of mirogabalin besylate in this patient population.

Data show that Diabetic Peripheral Neuropathic Pain ("DPNP") is a common chronic complication in people with diabetes and prediabetes. The most common symptom in patients is symmetrical peripheral neuropathic pain, mainly affecting the distal limbs, but it can also manifest as mononeural pain or brachial plexus and lumbosacral plexus neuralgia. Due to various reasons in the past, the diagnosis and treatment of DPNP have not been given sufficient attention, causing many patients to suffer from pain symptoms over the long term.

Yoshihiko Uchida, President of Daiichi Sankyo (China), stated that Delijing is another significant achievement resulting from Daiichi Sankyo's many years of dedication in this field. In the future, the company will continue to accelerate innovation, build a robust, sustainable, and resilient product pipeline, and collaborate with the government, medical institutions, and other parties to enhance the accessibility of innovative drugs, providing high-quality products for patients worldwide.