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NICE recommends STADA and Calliditas’ Kinpeygo to treat rare kidney disease IgAN

2024-02-09

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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.

AffeNational Institute for Health and Care Excellence (NICE)s when IgA accumulates in tCalliditas Therapeuticslammation and scarrKinpeygochbudesonideto kidney failure.IgA nephropathy (IgAN)kidney disease

Patients can experience a broad range of symptoms,IgANluding bone and joint pain, fatigue and muscle weakneinflammationhe coscarringprogresses, chronic kidney failure and associated infections can lead to hospitalisation.

Kinpeygo has been specifically recommended for use on the NHSbone and joint painesfatigueoptiomuscle weaknessprimary IgAN when there is a risk ochronic kidney diseasession in adults infectionsne protein-to-creatinine ratio of 1.5g/g or more.

Kinpeygoo outlined that the drug must be used as an add-on to optimised standard care, including the highest primary IgANcensed 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 tangiotensin-converting enzyme (ACE)e to patients in the UK in spring 2024.

STADAubmission 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 isKinpeygofective than standard care alone, noting that "targeted-release [KinpeygACE-inhibitor ACEshowed 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 treatsKinpeygot increases "the likelihood that people may avoid or delay the need for dialysis or a kidney trKinpeygo".

Paul Burden, vice presidenKinpeygoDA UK, said: “Supported by this positive NICE appraisal, we loIgANorward to bringing the UK’s first approved treatment to patients with primary IgAN, a progressive, rare kidney disease, within the next few months.”

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