26th Jun 2023 08:38
(Alliance News) - GSK PLC on Monday celebrated several regulatory approvals for new drug therapies, including treatments for shingles.
The Japanese Ministry of Health, Labour & Welfare has approved an updated indication for Shingrix, the London-based pharmaceutical company's vaccine for the prevention of herpes zoster in adults aged 50 and over.
The approval significantly expands the vaccine's availability in Japan, and now includes all adults aged 18 and over considered to be at increased risk of shingles by their healthcare provider.
Separately, GSK said that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending authorisation of daprodustat for the treatment of symptomatic anaemia, associated with chronic kidney disease in adults on chronic maintenance dialysis.
Daprodustat belongs to a novel class of oral medicines which are being studied for the treatment of anaemia of CKD in adult patients not on dialysis and on dialysis.
The committee's opinion is based on data from three global phase III trials in dialysis patients from the Ascend clinical trial programme, including Ascend-D.
Ascend-D is a non-inferiority trial which assessed the efficacy and safety of daprodustat for the treatment of anaemia of CKD in adult patients on dialysis with a comparator of a standard of care erythropoiesis-stimulating agent therapy.
GSK shares were trading 0.2% higher at 1,428.00 pence each in London on Monday morning.
By Holly Beveridge, Alliance News reporter
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