SIGA's Tepoxx Gets Regulatory Approval In Japan For Treatment Of Orthopoxviruses

(RTTNews) - SIGA Technologies, Inc. (SIGA), Thursday announced that its tecovirimat 200 mg capsules, traded as TEPOXX, has secured regulatory approval in Japan for the treatment of smallpox, mpox, cowpox, as well as complications following smallpox vaccination in adults and pediatric patients weighing at least 13 kg.

The antiviral treatment, marketed as Tpoxx in the U.S., is a highly targeted small-molecule antiviral that inhibits the VP37 protein found on the surface of all Orthopoxviruses. It stops the virus from exiting infected cells, slowing the spread of the infection.

The treatment was approved by the Pharmaceuticals and Medical Devices Agency, and the Japan Ministry of Health, Labour and Welfare.

The Japanese approval is based on data from 15 clinical trials of oral Tepoxx, demonstrating a reduction in mortality and viral load, no drug-related serious adverse events, and quantifiable pharmacokinetics within efficacious dose ranges.

Tokyo-based Japan Biotechno Pharma Co., Ltd. acts as an exclusive distributor of Tepoxx to the nation's national stockpile, the pharmaceutical company added.

During the pre-market hours, SIGA's stock is climbing 2.66 percent, to $6.17 on the Nasdaq.