BRIEF — GSK's daprodustat closer to Japanese market

29 October 2018

GlaxoSmithKline (LSE: GSK) has moved closer to realizing its strategy of submitting a regulatory filing for daprodustat in Japan next year.

The UK pharma major has announced results from the second of three pivotal studies the filing, after the first trial yielded positive findings too.

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor being investigated as a potential treatment for anemia associated with chronic kidney disease (CKD).

In the newly-announced results from the 52-week study of 271 haemodialysis-dependent patients, oral daprodustat met its primary endpoint of non-inferiority to darbepoetin alfa IV injection, as measured by mean change from baseline in hemoglobin levels over weeks 40 to 52.

Results from the third study in non-dialysis dependent patients are anticipated in the first half of 2019.

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