The National Institute for Health and Care Excellence (NICE) has recommended STADA and Calliditas Therapeutics’ targeted-release Kinpeygo (budesonide) to treat a subset of patients with IgA nephropathy (IgAN), a rare kidney disease.
Affecting approximately 14,000 people in England, IgAN occurs when IgA accumulates in the kidneys, causing inflammation and scarring, which can lead to kidney failure.
Patients can experience a broad range of symptoms, including bone and joint pain, fatigue and muscle weakness, and as the condition progresses, chronic kidney disease and associated infections can lead to hospitalisation.
Kinpeygo has been specifically recommended for use on the NHS in England and Wales as an option for treating primary IgAN when there is a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5g/g or more.
NICE also outlined that the drug must be used as an add-on to optimised standard care, including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated.
STADA, which holds the commercial rights for the drug in the UK, European Economic Area member states and Switzerland, said it intends to supply and make the drug available to patients in the UK in spring 2024.
The submission was supported by positive results from the NeflgArd randomised, double-blind trial comparing targeted-release Kinpeygo plus standard care, including maximally tolerated RASi therapy with an ACE-inhibitor or ARB, to standard care plus placebo.
In its guidance, NICE outlined that the clinical trial evidence suggests that targeted-release Kinpeygo plus standard care is more effective than standard care alone, noting that “targeted-release [Kinpeygo] showed benefit on urine protein-to-creatinine ratio and estimated glomerular filtration”.
The agency added that, as Kinpeygo is now the first licensed treatment that specifically treats IgAN, it increases “the likelihood that people may avoid or delay the need for dialysis or a kidney transplant”.
Paul Burden, vice president of STADA UK, said: “Supported by this positive NICE appraisal, we look forward to bringing the UK’s first approved treatment to patients with primary IgAN, a progressive, rare kidney disease, within the next few months.”