- Kidney-disease drug developer Akebia Therapeutics ( NASDAQ: AKBA ) added ~28% in the morning hours Thursday after GSK ( GSK ) announced that the FDA approved its anemia treatment Jesduvroq for adults on dialysis due to chronic kidney disease (CKD).
- An oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor similar to Jesduvroq, Akebia's ( AKBA ) lead candidate vadadustat, is currently in Phase 3 development.
- After the agency rejected the treatment for CKD-linked anemia in early 2022, the company said in December that the FDA issued an interim response to an appeal, requesting additional information.
- The company expected to submit the required data in January, seeking to hear a response to the appeal within 30 days.
- Biotech FibroGen ( FGEN ) is advancing its HIF-PH inhibitor roxadustat for anemia in partnership with Astellas Pharma ( OTCPK:ALPMF ) ( OTCPK:ALPMY ) and AstraZeneca ( AZN ). Roxadustat is approved in China, Europe, Japan, and several other countries to treat anemia in CKD patients, irrespective of their dialysis status.
- Seeking Alpha contributor Fade The Market argued in October that the FDA's decisions to reject vadadustat "significantly decrease the likelihood of the product's approval soon."
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Akebia jumps 28% after FDA nod for GSK kidney disease therapy