Otsuka Pharmaceutical has received regulatory approval from Japanese authorities for Samsca for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD).
The approval is for Samsca’s 7.5mg and 15mg tablet forms for extended use for the additional indication of ADPKD.
In addition, the new dosage form of 30mg Samsca tablets has received approval for the indication of ADPKD.
Samsca is currently used in 14 countries and territories worldwide as an aquaretic drug, which facilitates excretion of only free water without electrolyte loss due to its antagonist action on vasopressin V2 receptors.
From 2004, several clinical trials were carried out in 15 countries on more than 1,400 patients with ADPKD.
The trials showed that Samsca has significantly suppressed the rate of increase in total kidney volume by around 50% more than a placebo.
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Otsuka Pharmaceutical CEO Taro Iwamoto said development of a pharmacotherapy for ADPKD, a rare disease leading to end stage renal failure, has been difficult.
"Lack of a fundamental therapy for this disease has over many years been a great difficulty for people with ADPKD," Iwamoto added.
"Through Samsca’s completely new mode of action, development of a new category of indications was possible.
"While rigorously pursuing safety and effectiveness, in the future we look forward to having something to present to patients who suffer from this disease, not only in Japan but all over the world."
The company submitted an application for regulatory approval in Europe in December 2013, while discussions are underway in consultation with the FDA in the US to expeditiously determine the path forward for resubmission.
Kyorin University School of Medicine professor of nephrology Eiji Higashihara said since there has been no drug treatment for ADPKD up to now.
"Physicians and other health care workers need to thoroughly know the indications of Samsca for treatment of ADPKD," Higashihara said.
"We further need to keep in close touch with the patients and their families in paying attention to safe use of Samsca. It is important that, through teamwork, we carefully nurture this medicine that has been developed here in Japan."
With Japanese approval, Otsuka becomes the first company in the world to obtain regulatory approval for a pharmacological treatment of ADPKD.
Image: Abdominal CT scan of an adult with autosomal dominant polycystic kidney disease. Photo: courtesy of Steven Fruitsmaak.