Japan urges development of Pfizer's Lyrica and will consider Normosang and Yondelis

The Study Committee on the Use of Unapproved Drugs within Japan's Ministry of Health, Labor and Welfare has recently decided to urge the Japanese subsidiary of USA-based pharmaceutical giant Pfizer to rapidly develop Lyrica (pregabalin) for the treatment of fibromyalgia syndrome, which was approved in the USA in June last year (Marketletter July 2, 2007).

The drugmaker's Japanese subsidiary is currently conducting clinical trials with the compound as a treatment for pain associated with herpes zoster and diabetic peripheral neuropathy. According to the MHLW, it is also preparing to conduct studies for the indication of fibromyalgia syndrome.

A patient group has urged the MHLW to expedite approval of the drug for this indication because, in Japan, it is reported that there are about two million patients with the disease. However, awareness of the condition among physicians and patients is very low.