Akebia joins GSK in US market for oral CKD anaemia drugs

The FDA has approved Akebia Therapeutics’ vadadustat as a treatment for anaemia caused by chronic kidney disease (CKD) in dialysis patients, becoming the first rival to GSK’s Jesduvroq.

Akebia’s drug, which like Jesduvroq (daprodustat) is an oral HIF-PHI inhibitor, will be sold as Vafseo in the US and is now approved in 37 countries worldwide. It was previously turned down by the FDA in 2021, which was concerned by data potentially linking the drug to clotting complications and liver damage, allowing GSK to beat it to the US market.

Both Jesduvroq and Vafseo provide an oral alternative to injectable therapies for anaemia based on recombinant erythropoietin (EPO), and are thought to stimulate the production of endogenous EPO in the body.

Anaemia is a common complication of CKD and can be exacerbated by dialysis, a treatment that aims to do the job of the kidneys by filtering the blood and removing excess fluid from it. There are estimated to be around 500,000 people who need dialysis for CKD at any time in the US, and almost 90% of dialysis patients are treated for anaemia.

Vafseo can be used in patients who have been on dialysis for at least three months, a slightly shorter period than the four months required for GSK’s drug. Another oral HIF-PHI inhibitor, FibroGen’s Evrenzo (roxadustat), was also rejected by the FDA in 2021.

Akebia hadn’t yet commented on its launch or pricing plans for the US at the time of writing, ahead of a conference call with analysts later today. It will sell Vafseo in the US market through its own commercial team and a partnership with CSL Vifor, a well-established provider of dialysis products.

The company partners the drug with Medice Arzneimittel Pütter in Europe, where it was approved for CKD patients on dialysis last year, after an earlier alliance with Otsuka fell through. In Japan, meanwhile, Vafseo has been cleared for use in both dialysis and non-dialysis patients and is sold by Mitsubishi Tanabe.

Akebia’s president and chief executive John Butler has previously indicated that a US launch of vadadustat would represent the company’s most significant commercial opportunity and market of approximately $1 billion a year.

There is also a considerable overlap between prescribers of Vafseo and Akebia’s only other approved therapy, Auryxia (ferric citrate) for iron deficiency anaemia (IDA) and hyperphosphataemia (HP), which brought in $170 million in revenues last year.

“At Akebia we are committed to kidney patients, a dedication that has driven our team to achieve this milestone,” said Butler. “We believe this commitment uniquely positions the company to execute a successful launch, designed to drive toward a potential new oral standard of care for dialysis patients.”