Nov 25 (Reuters) - The U.S. Food and Drug Administration

has approved Otsuka's 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' Fabhalta, Travere Therapeutics' ( TVTX )

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 )

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.