The Akebia Therapeutics Inc (NASDAQ: AKBA) stock price rose 18.92% after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) about Vafseo™ (vadadustat).
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The CHMP adopted a positive opinion recommending that the European Commission (EC) approves Vafseo™ (vadadustat). The drug treats symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
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Vafseo™ (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that treats symptomatic anaemia in patients suffering from chronic kidney disease (CKD). The European Commission will review the CHMP’s recommendation before making its final decision in two months.
Investors cheered the development, given that a positive recommendation from the CHMP carries a lot of weight and almost guarantees that the European Commission will approve the drug once it earns a positive review from the CHMP.
Still, there is a possibility that the EC will go against the CHMP’s recommendation as the body charged with the final decision, but this is rarely the case. The European Commission’s decision will apply to all the 27 EU member states, including Norway, Iceland, and Liechtenstein.
The CHMP’s positive opinion was based on analysing the data from the drug’s comprehensive development journey involving over 7,500 patients, including a global phase 3 clinical trial of vadadustat as a treatment for anaemia due to CKD in adult patients on dialysis.
John P. Butler, Akebia Therapeutics’ CEO, said: “We are extremely pleased by the CHMP's positive opinion of our marketing authorisation application for Vafseo for patients on dialysis. We are driven to better the lives of people impacted by chronic kidney disease, and a positive opinion is a critical step toward delivering on this purpose. We believe more treatment options are needed for patients with anaemia on dialysis, and if we receive a positive EC decision, Vafseo could offer an oral treatment to help address this need. This is also an important milestone in our process to identify and secure a potential partner in Europe to bring Vafseo to those patients.”
Over 1.42 million AKBA shares had changed hands at writing.
*This is not investment advice.
Akebia Therapeutics (AKBA) stock price.
The Akebia Therapeutics (AKBA) stock price rallied 18.92% to trade at $0.8784, from Thursday’s closing price of $0.7400.
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