Otsuka/Akebia receive vadadustat CRL

Akebia announced the FDA has issued a CRL regarding the vadadustat NDA for the treatment of anemia due to CKD. According to the press release, FDA concluded that the data in the NDA “do not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients.” FDA expressed safety concerns including failure to meet non-inferiority in MACE in the non-dialysis patient population, increased risk of thromboembolic events, driven by vascular access thrombosis in dialysis patients, and the risk of drug-induced liver injury. Additionally, in the CRL, FDA suggested that Akebia investigate ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials. Akebia will be working with its partners to evaluate the CRL, and it intends to request a meeting with FDA to evaluate next steps. Importantly, Akebia will host a conference call Wednesday, March 30 at 6:00 PM ET to discuss the CRL.

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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