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news.Japan-based Otsuka Pharmaceutical has received marketing authorization from the European Commission for Jinarc (tolvaptan) to treat autosomal dominant polycystic kidney disease (ADPKD) in adults.
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The drug is indicated for ADPKD patients who have chronic kidney disease (CKD) stage one to three at initiation of treatment with evidence of rapidly progressing disease.
Tolvaptan is now the first approved pharmaceutical therapy to be licensed in Europe to treat the underlying pathophysiology of ADPKD.
University Medical Centre Groningen expert in the field of polycystic kidney disease professor Ron Gansevoort said: "Until now, healthcare professionals have focused on treating the signs and symptoms of ADPKD, with no specific treatment available to treat the disease.
"Tolvaptan represents a significant medical breakthrough in the management of ADPKD. For the first time, healthcare professionals can modify the progression of the disease and preserve kidney function, with the potential to improve patients’ quality of life and long-term outcomes."
The marketing authorisation is based on the data from a randomized, double-blind and placebo-controlled Phase III TEMPO 3:4 trial carried out over a three-year period.
In this trial, the rate of total kidney volume (TKV) increase over three years was significantly less for tolvaptan-treated subjects than for subjects receiving placebo: 2.80% per year vs 5.51% per year, respectively.
In addition, tolvaptan showed a statistically significant reduction in the risk of multiple events of worsening kidney function, kidney pain, hypertension or albuminuria.