GlaxoSmithKline clears regulatory hurdle in Japan for 'Duvroq'

(Sharecast News) - GlaxoSmithKline announced the approval of a Japanese New Drug Application (JNDA) by the Ministry of Health, Labour and Welfare in that country on Monday, for 'Duvroq', or daprodustat tablets.

The FTSE 250 company described Dubroq as an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with the approval being for the treatment of patients with anaemia due to chronic kidney disease (CKD).

It said anaemia is common in patients with CKD because the kidneys no longer produce adequate amounts of erythropoietin, a hormone involved in prompting the production of red blood cells.

HIF-PHIs are a new class of drug that trigger the body's adaptations to hypoxia, or oxygen deprivation, and encourages the bone marrow to make more red blood cells and so reduce anaemia, thereby benefiting patients.

The board said the JNDA was mainly based on positive data from the phase 3 programme conducted in Japan.

It said the studies evaluated Duvroq for the treatment of anaemia in patients across the spectrum of CKD from stages three to five.

That included patients on dialysis, including both hemo- and peritoneal dialysis, and those not on dialysis, regardless of prior anaemia treatment with erythropoiesis-stimulating agents (ESAs).

In contrast to the current standard of care in patients with CKD which requires injections, Duvroq offered convenience, the board noted, with oral administration and flexibility with once-daily dosing for dialysis and non-dialysis patients.

Daprodustat was currently not approved as a treatment for anaemia due to CKD or any other indication anywhere else in the world other than in Japan.

The company said the ongoing phase 3 global programme, which includes two cardiovascular outcome studies 'ASCEND-D' and 'ASCEND-ND', would support additional regulatory submissions across the world.

Duvroq is one of the medicines in GSK's portfolio of innovative specialty care products, and in Japan, it would be exclusively distributed by Kyowa Kirin (KKC), following the strategic commercialisation deal announced in 2018.

GSK said KKC had "strong established expertise and experience" in the treatment of anaemia due to CKD to ensure availability of the innovative medicine to patients.

Commercial promotional launch activities will be led by KKC, with GSK supporting scientific engagement through medical science liaisons.

"The approval of Duvroq brings a new, convenient oral treatment option to nearly 3.5 million patients in Japan who have anaemia associated with renal disease," said chief scientific officer and president of research and development Dr Hal Barron.

"We are pleased with this first approval and look forward to sharing data from our ongoing phase III programme as we seek to help many more patients suffering with this disease around the world."

At 0922 BST, shares in GlaxoSmithKline were ip 0.05% at 1,647.8p.