GSK Submits Shingrix Regulatory Application in Japan for Adults 18 and Older

 GSK PLC said Tuesday that Japan's Ministry of Health, Labour and Welfare has accepted its regulatory application for its shingles-prevention treatment, Shingrix, so that it is used in adults age 18 and older who are at increased risk.

The U.K. pharmaceutical company, formerly known as GlaxoSmithKline, said Shingrix has already been approved in the country for adults age 50 and older.

The company said Shingrix's application was based on six clinical trials in patients 18 and older who had undergone recent blood-forming cells (stem cell)transplantation, kidney transplant, or have blood cancer, solid tumors or HIV.

"Shingrix is also recommended in the U.S. by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices as the preferred vaccine for the prevention of shingles and related complications for immunocompetent adults aged 50 years and older," the company said.

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