In a regulatory filing, the Cambridge, Massachusetts-based company indicated that it plans to “refocus its strategic priorities” and lay off 42% of its workforce.
Akebia CEO John Butler/Courtesy of Business Journals
On March 30, the U.S. Food and Drug Administration rejected Akebia Therapeutics’ New Drug Application (NDA) for vadadustat to treat anemia due to chronic kidney disease (CKD). The rationale behind the rejection was safety concerns.
In a regulatory filing, the Cambridge, Massachusetts-based company indicated that it plans to “refocus its strategic priorities” and lay off 42% of its workforce. As of the end of 2021, Akebia had 426 full-time staffers.
Akebia stated, “This workforce reduction is expected to be substantially completed by the end of the second quarter of 2022. The reduction in force reflects the Company’s determination to refocus its strategic priorities around its commercial product, Auryxia, and its development portfolio, and is the first step in a cost savings plan to significantly reduce the Company’s expense profile in line with being a single commercial product company.”
The company will offer separation benefits, including severance payments, healthcare coverage and related benefits to the affected employees. It is also planning to record a one-time restructuring charge of about $12 million related to severance, non-cash stock-based compensation expense, healthcare and related benefits in this year’s second quarter. Akebia believes this will result in about a $60 to $65 million reduction in net cash needed for operational activities through the end of 2023.
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. It is designed to mimic the effect of altitude on oxygen availability. The FDA’s concerns over safety included thromboembolic events and the possibility of drug-induced liver damage. The agency stated the drug’s benefit-risk profile wasn’t supported by the data for dialysis and non-dialysis patients.
Akebia had used a priority review voucher to cut the wait time for the FDA’s review.
At the time of the Complete Response Letter from the FDA, John Butler, chief executive officer of Akebia, noted, “We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD. We continue to believe the data are supportive of a positive benefit-risk assessment of vadadustat for patients with anemia due to CKD, particularly in dialysis patients.”
The FDA did provide a glimmer of hope, suggesting vadadustat might demonstrate an improved benefit-risk profile via new clinical trials. The company plans to discuss the CRL with the FDA and its collaboration partners.
Although Akebia seemed surprised by the rejection, perhaps it shouldn’t have been. In September 2020 the company announced results for the drug from two Phase III trials, and the study did not meet multiple safety endpoints at that time. The drug is approved in Japan for dialysis and non-dialysis dependent patients for anemia caused by CKD.
Akebia’s sole commercial product, Auryxia (ferric citrate), is indicated for hyperphosphatemia (HP) in adults with CKD who are on dialysis and for iron deficiency anemia (IDA) in adults with CKD who are not on dialysis.
On March 1, Akebia reported its full-year 2021 and fourth-quarter financial results. Full-year revenue was $213.6 million. Net product revenue for the year was $142.2 million. That figure was entirely based on product sales of Auryxia. As of December 31, 2021, the company had $149.8 million in cash and cash equivalents.
