U.S. FDA declines to approve Akebia’s anemia drug on safety concerns

Reuters - 30/03/2022 - The U.S. health regulator has declined to approve Akebia Therapeutics' drug to treat anemia caused by chronic kidney disease on safety concerns in non-dialysis patients, the company said on Wednesday.

The drugmaker's shares plunged about 73% to a record low of 67 cents in afternoon trade.

Vadadustat was inferior in its safety profile when compared with the current standard of care for patients not dependent on dialysis, the U.S. Food and Drug Administration noted.

The drug posed an increased risk of blood clot formations and drug-induced injuries to the liver, the agency added.

Vadadustat is the second drug from the HIF-PH (Hypoxia-Inducible Factor Prolyl Hydroxylase) inhibitor class to be rejected by the FDA, after FibroGen-AstraZeneca's roxadustat in August 2021.

The regulator indicated in its letter that Akebia could explore conducting new studies to potentially show a favorable benefit-risk assessment of the drug.

HIF-PH inhibitors are a class of oral drugs designed to boost production of red blood cells by mimicking the body's response at high altitudes.

Other HIF-PH inhibitors undergoing clinical studies include GlaxoSmithKline's daprodustat, which helped improve haemoglobin levels in late-stage trials, according to data released in July 2021.

Both GSK's daprodustat and Akebia's vadadustat are currently approved in Japan for treating anemia in chronic kidney disease (CKD) patients. Akebia, along with its Tokyo-based partner Otsuka Pharmaceutical is also seeking marketing authorization for vadadustat in the European Union.

Anemia is a common complication of CKD, a condition in which a person's kidneys cannot filter blood efficiently, causing waste and fluid to build up in the body.

According to Centers for Disease Prevention and Control, about 37 million adults in the United States are estimated to have CKD.

By Reuters Staff



Posted on 30 March 20226 April 2022