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.|