Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced that China’s Center for Drug Evaluation (CDE) has accepted its market approval filing for mirogabalin besylate, a novel chronic pain treatment. The drug is specifically targeted at diabetic peripheral neuropathic pain (DPNP), a condition that affects a significant number of patients with diabetes and is characterized by severe nerve pain in the extremities.
Mechanism of Action and Global Approvals
Mirogabalin is a selective ligand that acts on the α2δ subunit of voltage-gated calcium channels, inhibiting the release of neurotransmitters involved in pain signaling. This mechanism allows it to provide effective analgesia for patients suffering from neuropathic pain conditions. The drug has already secured market approvals in Japan, where it was approved for the treatment of peripheral neuropathic pain in January 2019 and for neuropathic pain more broadly in March 2022.
Market Potential in China
The acceptance of the market approval filing by the CDE marks a significant step forward for Daiichi Sankyo in expanding its presence in the Chinese pharmaceutical market. Diabetic peripheral neuropathic pain (DPNP) is a prevalent condition among diabetic patients, and the introduction of mirogabalin could offer a new therapeutic option for those who are inadequately managed by existing treatments. This move underscores Daiichi Sankyo’s commitment to bringing innovative pain management solutions to patients globally.-Fineline Info & Tech
