GSK gets an approval in Japan, a recommendation in Europe

GSK announced two significant advancements on Monday, with the approval of an updated indication for Shingrix in Japan, as well as a positive opinion from the European Medicines Agency for daprodustat.

The FTSE 100 pharmaceuticals giant said Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, was initially approved in 2018 by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the prevention of shingles in adults aged 50 years and over.

However, the new approval signified a significant expansion in its availability by including all adults aged 18 and over who were considered to be at an increased risk of shingles.

Shingles, caused by the reactivation of the varicella-zoster virus (VZV) in individuals with a weakened immune system, poses a significant health risk to older adults.

“The MHLW approval was granted based on data from six clinical trials involving adults aged 18 years and over who were among those at increased risk for shingles, including those who had undergone recent stem cell transplantation or kidney transplant, or who had blood cancer, solid tumours or HIV,” GSK said in its statement.

In Europe, meanwhile, daprodustat received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending its authorisation for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

The positive opinion was based on data from three global phase three trials, including ASCEND-D, ASCEND-ID, and ASCEND-TD, which demonstrated the efficacy and safety of daprodustat compared to standard of care erythropoiesis-stimulating agent (ESA) therapy.

GSK said the results of the trials were published in reputable medical journals such as the New England Journal of Medicine, Journal of the American Medical Association (JAMA) Internal Medicine, and the Clinical Journal of the American Society of Nephrology (CJASN).

“CKD is an increasing global health burden affecting 700 million patients worldwide, with an estimated one in seven patients also developing anaemia, resulting in increased morbidity, mortality and reduced quality of life,” the company explained.

“When not adequately managed in certain patients, it can result in exhaustion and limit the ability to function in day-to-day life.

“When left untreated or undertreated, anaemia of CKD is associated with poor clinical outcomes and leads to a substantial burden on patients and healthcare systems.”

At 0814 BST, shares in GSK were up 0.29% at 1,429.4p.

Reporting by Josh White for Sharecast.com.