Drug for Treating Autosomal Dominant Polycystic Kidney Disease Gets Expanded Indication

According to a story from businesswire.com, Otsuka Pharmaceutical Europe Ltd recently announced that its product JINARC, also known as tolvaptan, now has an expanded therapeutic indication after a recent approval from the European Commission. When it was originally approved, tolvaptan was cleared for the treatment of autosomal dominant polycystic kidney disease in patients with stage 1-3 of chronic kidney disease; the new expansion now will allow for the drug to be used in patients with stage 4 disease as well. The submission of additional data demonstrated that tolvaptan was safe to use in patients with advanced disease. Otsuka Pharmaceuticals specializes in the development of medications that utilize innovative mechanisms of action and aim to address previously unmet medical needs.

About Autosomal Dominant Polycystic Kidney Disease

Autosomal dominant polycystic kidney disease (ADPKD) is a potentially lethal disorder that affects kidney function. The disease is linked to disorders of the PKD1 and PKD2 genes. Cysts filled with fluid develop and enlarge the organs until they eventually fail. The presentation of ADPKD can vary substantially from case to case; many patients do not exhibit symptoms of kidney dysfunction until they reach their 40s or 50s. Symptoms include liver cysts, uremia (due to kidney failure), anemia (due to chronic kidney disease), berry aneurysm, hypertension, loin pain, ballotable kidneys, and haematuria. Treatment may involve kidney transplant, dialysis, and certain medications. Tolvaptan can halt the progression of the disease for an average of three years. To learn more about ADPKD, click here.

Treatment Protocol

ADPKD is the fourth most frequent cause of kidney failure. The new expanded indication will provide patients with stage 4 CKD and ADPKD an alternative option for treatment that they would not have had access to before. Data from clinical trials suggest that, when considering to use tolvaptan for treating patients with stage 4 CKD, it would be wise to weigh the risks and benefits carefully; in some cases, it may not be worthwhile. However, there will be some patients that will benefit from using it. The study also recommends that treatment and monitoring should be done only by caregivers with experience and expertise in the treatment of ADPKD.


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