- Akebia Therapeutics Inc (NASDAQ:AKBA) announced three poster presentations at the National Kidney Foundation (NKF) Spring Clinical Meetings 2022.
- Poster data demonstrated that overall, vadadustat did not increase the risk of dialysis access thrombotic events (TE) compared to darbepoetin alfa (DA) among 1,947 patients who received vadadustat and 1,955 patients who received DA.
- Initial presentation at ASN Kidney Week 2021, the number of vascular access site thrombosis during the INNOVATE studies was 34 (1.7%) on vadadustat vs. 41 (2.1%) on DA.
- Of those, 8 of 34 (23.5%) on vadadustat vs. 16 of 41 (39.0%) on DA were deemed serious.
- Also Read: FDA Places Partial Hold On Vadadustat Pediatric Studies, Akebia Cuts Over 40% Staff.
- Poster #280 at NKF SCM22 also evaluated a shorter time, "on treatment + 28 days", during which the number of vascular access site thrombosis was 28 (1.4%) on vadadustat vs. 40 (2.0%) on DA.
- 7 of 28 (25.0%) on vadadustat vs. 16 of 40 (40.0%) on DA were deemed serious.
- The analyst acknowledged that a key limitation of these analyses is that the investigators were not blinded to randomized treatment.
- Hence possibly reaching its conclusion on the NDA for vadadustat, the FDA relied more on the TE data as adjudicated by the Clinical Endpoint Committee (CEC) investigator-reported data.
- The adjudicated CEC data appeared incrementally less favorable to VADA, with overall TE rates of 8.7% for vadadustat vs. 7.6% for DA, leading to a hazard ratio of 1.20 and a 95% confidence interval of 0.96-1.49 (not significant).
- HC wainwright maintains Neutral for Akebia in the wake of the CRL and the uncertainty that it creates for the company's outlook and vadadustat.
- Price Action: AKBA shares are down 2.68% at $0.56 during the market session on the last check Thursday.
