GSK reaches endgame of race to develop anaemia drug
pharmafile | November 25, 2016 | News story | Research and Development, Sales and Marketing | AstraZeneca, Daprodustat, GSK, GlaxoSmithKline, anaemia
GlaxoSmithKline has announced that they will begin Phase 3 development of their anaemia drug, daprodustat. The drug is an oral treatment for anaemia associated with chronic kidney disease and will be tested through two trials, with a combined total of 7,500 patients.
Daprodustat’s action is presumed to function by stimulating the body’s production of red blood cells that is usually reactive to oxygen levels in the blood. The drug thereby mimics the body’s reaction to low oxygen levels in the environment thereby increasing the natural production of EPO in the kidneys.
The drug is an oral pill and could be set to replace the current methods of injectable anaemia treatments, such as erythropoietin (EPO). EPO is a treatment that is now synonymous with cycling scandals. The trials will be hoping to study the effects on anaemia and also to assess any potential risk of a cardiovascular event. In both studies, the co-primary endpoints are time to first occurrence of major adverse cardiovascular events (MACE) and mean change in haemoglobin between the baseline and efficacy period (mean over Weeks 28-52).
Julian Jenkins, vice president and medicine development leader responsible for the daprodustat programme, said: “For many patients with chronic kidney disease, treating their anaemia comes with risks associated with cardiovascular safety and injectable administration. The start of phase III studies of daprodustat is an important step in our work to explore whether daprodustat could address those risks and provide a potential alternative, oral treatment option.”
The product is potentially worth $450 million by 2020, according to Credit Suisse. However, AstraZeneca is involved in the race to market with an estimation by FibroGen (who are developing roxadustat) to file a marketing authorisation for its drug, in the US, by 2018.
Ben Hargreaves
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