The United States Food and Drug Administration (US FDA) has endorsed Trutakna (atacicept-vymj), a novel treatment produced by Vera Therapeutics to lower protein levels in the urine of adults living with primary immunoglobulin A (IgA) nephropathy who face a high risk of disease progression.
The newly approved medicine is the first of its kind to block both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), two proteins that support the growth and survival of immune cells.
By targeting these pathways, the therapy reduces the production of the abnormal IgA antibodies responsible for damaging the kidneys.
IgA nephropathy is a chronic kidney disorder in which defective IgA antibodies accumulate in the kidneys, triggering inflammation and gradual tissue injury.
As the condition worsens, excessive protein passes into the urine, leading to declining kidney function and, in severe cases, kidney failure.
The approval follows results from a randomised, double-blind, placebo-controlled clinical trial involving adults with biopsy-confirmed IgA nephropathy.
Participants who received a 150-milligram weekly injection of Trutakna recorded an average 46 per cent reduction in proteinuria after nine months compared with those given a placebo.
The FDA permitted the therapy accelerated approval based on its ability to significantly reduce protein leakage into the urine.
However, regulators noted that evidence is still needed to confirm whether the medicine can slow long-term deterioration of kidney function.
A larger ongoing study will continue to evaluate its long-term clinical benefits.
The agency said continued marketing authorisation will depend on positive findings from the confirmatory trial.
Health officials also cautioned that Trutakna suppresses the immune system, increasing the likelihood of infections.
Patients are advised to undergo screening for active infections before beginning treatment and should be closely monitored throughout therapy.
The FDA further recommends avoiding live vaccines within 30 days before starting the medication and during the course of treatment because of the potential risk of infection.
Administered as a once-weekly injection beneath the skin, Trutakna also received Priority Review and Breakthrough Therapy designation, reflecting its potential to address an important unmet medical need for people living with IgA nephropathy.
By: Magdalene Agyeiwaa Sarpong