GSK Can Seize Chance In Anemia After Rivals Rejected But FDA Caution Will Remain

Daprodustat Filing Accepted In US

 
• By Andrew McConaghie

GSK’s drug is the first in the class to show non-inferiority to standard therapy in safety, but the data still contains areas of doubt.

US FDA entrance
Following the rejection of rival candidates from Fibrogen/AstraZeneca and Akebia, GSK is confident its data will be enough to secure approval • Source: Alamy

After the regulator’s rejection of two rivals, GlaxoSmithKline’s daprodustat could be the first in a new class of oral anemia drugs approved in the US, but concerns about class safety may mean its use is limited.

The company confirmed on 19 April that the US Food and Drug Administration had accepted the filing of the oral...

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