FDA to take another look at Akebia's rejected kidney drug
Will the second review work out better than the first? Akebia Therapeutics said this morning that the FDA is taking another look at its complete response letter for its potential treatment for anemia due to chronic kidney disease, which was rejected last March due to safety concerns.
The company, which saw its stock price fall by more than 65% at the time of the rejection of vadadustat, said the FDA had requested a new trial and that the safety questions centered on the drug’s “increased risk of thromboembolic events, driven by vascular access thrombosis in dialysis patients, and the risk of drug-induced liver injury.”
To read Endpoints News become a free subscriber
Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters