Batch of drug approvals in Japan

In what was a busy day for the Japanese regulator, the Ministry of Health, Labor and Welfare (MHLW) yesterday announced a number of approvals, both new drugs and new indications.

Among these, Japan's Daiichi Sankyo (TYO: 4568) obtained approval in Japan to change the indication of the analgesic Tarlige (mirogabalin besilate) tablets from “peripheral neuropathic pain” to “neuropathic pain.”

Neuropathic pain is pain caused by lesions or diseases of the somatosensory nervous system and is classified into peripheral neuropathic pain and central neuropathic pain (CNP), according to the anatomical location of the nerve damage site that causes the pain. CNP is pain that arises from central nerve injury or impairment such as spinal cord injury and central post-stroke pain.