Akebia Therapeutics ( NASDAQ: AKBA ) added ~11% pre-market Friday after announcing that an independent group of medical experts has recommended the approval of its lead asset, vadadustat, as a treatment for anemia linked to chronic kidney disease in adults on dialysis.
With the so-called positive opinion from the Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the oral therapy is set for regulatory clearance in the EU as Vafseo.
Specifically, the CHMP called for its approval for anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. The decision will next be reviewed by the European Commission (EC) which is expected to issue a final decision in about two months.
“This is also an important milestone in our process to identify and secure a potential partner in Europe to bring Vafseo to those patients,” John Butler, Chief Executive of Akebia ( AKBA ), remarked.
The decision comes at a time the company is struggling to bring vadadustat to the U.S. market after the FDA declined the treatment for anemia linked to CKD in March 2022.
Seeking Alpha contributor Fade The Market issued a Sell rating on Akebia ( AKBA ) in October, arguing that the company’s “pipeline is empty outside of Vadadustat.”
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Akebia jumps 11% on EU nod to approve kidney disorder therapy