FDA Approves For Akebia Therapeutics' Vafseo For Kidney Disease Associated Anemia
Portfolio Pulse from Vandana Singh
The FDA has approved Akebia Therapeutics Inc's (NASDAQ:AKBA) Vafseo for anemia due to chronic kidney disease in adults on dialysis. Vafseo, a once-daily oral treatment, is now approved in 37 countries. The approval is based on the INNO2VATE program and post-marketing data from Japan. Akebia plans to commercialize Vafseo in the U.S. with its commercial team, aiming to make it the new oral standard of care. Analysts predict peak sales of $954 million by 2031. Following the news, AKBA shares surged 18.8% in premarket trading.
March 28, 2024 | 1:50 pm
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Akebia Therapeutics receives FDA approval for Vafseo, a treatment for anemia in CKD patients on dialysis. The company plans U.S. commercialization, with analysts predicting $954 million in peak sales by 2031. Shares surged 18.8% in premarket trading.
The FDA approval of Vafseo represents a significant milestone for Akebia Therapeutics, potentially transforming the treatment landscape for anemia in CKD patients on dialysis. The approval, based on robust efficacy and safety data, positions Vafseo as a promising new oral standard of care. The positive market reaction, reflected in the 18.8% premarket share price surge, underscores investor confidence in Vafseo's commercial potential. Analysts' high sales forecast further validates the drug's market viability and Akebia's strategic positioning.
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IMPORTANCE 95
RELEVANCE 100