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New Japanese approvals include first OK for GSK’s anaemia drug Duvroq

And Novartis gets green light for non-small cell lung cancer drug Tabrecta


A flurry of new approvals by the medicines regulator in Japan includes a world-first for GlaxoSmithKline’s Duvroq for anaemia caused by chronic kidney disease, and no fewer than five for Novartis, including its new lung cancer drug Tabrecta.

GSK’s drug – an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) – becomes a treatment option for almost 3.5m people in Japan with anaemia caused by CKD, and the first competitor to Astellas’ HIF-PHI Evrenzo (roxadustat), which was approved there last September.

GSK co-developed Duvroq (daprodustat) with Kyowa Kirin, which has a long heritage in the CKD anaemia market with its injectable erythropoiesis-stimulating agent (ESA) Espo (epoetin alfa) and will be the exclusive distributor of the drug in Japan.

Duvroq and Evrenzo have been developed to provide an alternative to ESAs, which along with dosing via injection or infusion also require cold storage.

At the moment Duvroq has an advantage over Evrenzo because its approved use covers patients regardless of whether they are on dialysis or not, while Astellas’ drug is specifically approved for those on dialysis. In January, however, Astellas filed for approval to expand use of its drug into the non-dialysis setting.

ESAs directly stimulate red blood cell production but can cause blood clots and other cardiovascular side effects. In contrast, HIF-PHI drugs stimulate endogenous production of erythropoietin, and their developers think this mechanism leads to lower but more consistent EPO levels in the blood, thus avoiding complications.

Analysts have suggested the HIF-PHI drugs could eventually generate several billions of dollars in annual sales.

Novartis approvals

The crop of new approvals for Novartis drugs in Japan is headed by a green light for Tabrecta (capmatinib), an oral MET inhibitor for METex14 mutation-positive non-small cell lung cancer (NSCLC).

Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type, in patents with  advanced or recurrent METex14+ tumours that can’t be treated with surgery. It is the second major country to approve the drug after the US earlier this year.

Novartis’ drug was beaten to the Japanese market in this indication by Merck KGaA’s rival MET inhibitor Tepmetko (tepotinib), which got the go-ahead from the Ministry of Health Labour and Welfare (MHLW) in March.

Approximately 3,000 patients are diagnosed in Japan each year with METex14 metastatic NSCLC, a particularly aggressive form of the disease, says Novartis.

Other MHLW approvals for Novartis included Mayzent (siponimod) for secondary progressive multiple sclerosis (SPMS) – already approved in the US and Europe for this indication – as well as chronic heart failure therapy Entresto (sacubitril/valsartan), and combination respiratory drugs Enerzair (glycopyrronium/indacaterol/mometasone) and Atectura (indacaterol/mometasone) for asthma.

This week also saw the Japanese regulator approve Novo Nordisk’s oral GLP-1 agonist drug Rybelsus (semaglutide) for type 2 diabetes.

Article by
Phil Taylor

30th June 2020

From: Regulatory



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