Otsuka's Jynarque garners FDA approval for autosomal dominant polycystic kidney disease

Otsuka Pharmaceutical announced that the FDA approved Jynarque (tolvaptan) as the first drug treatment in the US to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). The company noted that the selective vasopressin V2-receptor antagonist will be sold in a 28-day treatment pack at a wholesale acquisition cost of $13 041.10.

The approval of Jynarque was based on results from two pivotal trials, with data from the Phase III REPRISE study showing that the drug reduced the rate of decline of kidney function by 35 percent over a 12-month period, compared to placebo, in patients with ADPKD. Meanwhile, results from the TEMPO 3:4 study demonstrated that Jynarque reduced the annual increase in total kidney volume by 49 percent versus placebo, while the treatment was found to lower the decline in kidney function by 30 percent compared to placebo.

According to Otsuka, because of the risks of serious liver injury, Jynarque is only available through a restricted distribution programme, with patients required to undergo testing for blood alanine and aspartate aminotransferases levels, as well as bilirubin before initiating treatment. Patients must also have testing at two weeks and four weeks after starting treatment, then monthly for 18 months and every three months thereafter.

Otsuka previously sought approval of Jynarque in the US for the treatment of ADPKD, although the FDA issued a complete response letter in 2013, asking the company to supply additional data on the safety and efficacy of the drug. The therapy was first cleared in 2014 in Japan, where it is sold as Samsca for the treatment of ADPKD, while the medicine has been authorised in a number of other markets, including Canada and Europe, where it is marketed as Jinarc.

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