Hopes fade for novel anaemia pills, but could Glaxo yet prevail?

Imagine the scenario: Glaxosmithkline, the wild card in the novel anaemia pill race, swoops in with a late but clean pivotal programme with daprodustat, serving up a HIF-PH inhibitor that regulators can approve with confidence. The mechanism finally delivers on its promise in anaemia with chronic kidney disease, with a safe and convenient oral option to replace EPO infusions that risk cardiotoxicity. This seems highly unlikely, unfortunately, given the failure of both Fibrogen and Akebia to generate convincing safety packages with their respective contenders, roxadustat and vadadustat. The former was rocked by a barely believable data error this week, and the latter failed a key cardiac safety test. Regulators therefore have very good reason to be wary of the class. Glaxo’s daprodustat holds the potential to swing opinion, but which way depends on the readout of two major pivotal trials, due in the second half. Consensus forecasts suggest that hopes are low: numbers have come down for vadadustat and daprodustat in the last 12 months, according to Evaluate Pharma, and roxadustat's are likely to follow soon. The HIF-PH inhibitors’ fate should be known by year end; it is hard to picture a resurrection.

The convoluted world of the HIF-PH inhibitors: destined to be big only in Japan? 
Company Rights and regions Status 
Astrazeneca US, China and others Filed in the US; adcom Jul 15
Fibrogen Certain US and China rights Filed in the US; adcom Jul 15
Astellas  Japan, Europe and others Filed in Europe, decision due by mid-year; marketed in Japan (as Evrenzo)
Akebia  US co-promote/profit share, royalties elsewhere Awaiting US FDA acceptance of NDA; marketed in Japan (sold by Mitsubishi as Vafseo)
Vifor Pharma  US profit share in dialysis population -
Otsuka  US co-promote, Europe, China and other regions Europe fillings due this year
Glaxosmithkline WW ex Japan Ascend-D and Ascend-ND readouts due H2 2021
Kyowa Kirin Japan Marketed in Japan (as Duvroq)
Source: Evaluate Pharma. 

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