US FDA approves Otsuka's drug for a type of kidney disease

By Sriparna Roy

Nov 25 (Reuters) - The U.S. Food and Drug Administration has approved Otsuka's 4578.T injectable drug to treat patients with a potentially life-threatening kidney disease, the health regulator's website showed on Tuesday.

The drug, branded as Voyxact, was approved to reduce proteinuria in patients with primary immunoglobulin A nephropathy, which causes inflammation in the kidneys and can eventually lead to the organ's failure.

The company did not immediately respond to Reuters' request for comment on pricing and availability.

Voyxact is a monoclonal antibody designed to be administered every four weeks, either through a caregiver or by the patient, providing the option of at-home convenience.

IgAN, also called Berger's disease, occurs when a type of antibodies called immunoglobulin A build up in the kidneys, causing inflammation while damaging tissues and leaking blood and protein into urine.

Voyxact joins a market that includes oral options such as Novartis' NOVN.S Fabhalta, Travere Therapeutics' TVTX.O Filspari and Calliditas Therapeutics' Tarpeyo. While Fabhalta is typically dosed twice a day, the other oral drugs are given once daily.

It also gives an upper hand to Otsuka in the battle for an effective new treatment with rival Vera Therapeutics' VERA.O atacicept, which reduced protein levels in patients' urine by 46% at 36 weeks.

In a late-stage study, Otsuka's therapy cut levels of protein in the urine of patients, or proteinuria, by 51.2% after nine months of treatment.

The company hopes this improvement will also result in improved kidney function over time, John Kraus, chief medical officer at Otsuka told Reuters ahead of the approval.

Otsuka is continuing the late-stage trial to study the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR), which indicates the kidneys' ability to filter toxins. The study is expected to be completed in early 2026.