FDA Accepts Otsuka’s Resubmission To Support A Regulatory Review Of Tolvaptan In The Treatment Of ADPKD

Tolvaptan has been studied in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) in a clinical trial program which included more than 3,165 trial participants exposed to at least one dose of tolvaptan across 18 trials[i] ADPKD is a progressive disease leading to kidney failure, diagnosed in 100,000 to 150,000 people in the U.S.[ii] April 2018 is the anticipated completion timing of the FDA’s review (based on Prescription Drug User Fee Act [PDUFA] timeline) Tokyo, Japan – November 9, 2017 – Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has accepted Otsuka’s resubmission to support a regulatory review of Otsuka’s New Drug Application (NDA) for tolvaptan in the treatment of adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Otsuka’s resubmission is a response to the Complete Response Letter (CRL) that FDA issued in August 2013. The FDA considers the resubmission to be filed as of October 24, 2017, with a Prescription Drug User Fee Act (PDUFA) action date of April 24, 2018. The NDA for the proposed indication for tolvaptan in adults with ADPKD is supported by an extensive clinical trial program. About Tolvaptan Tolvaptan is a selective vasopressin V2-receptor antagonist. By selectively blocking vasopressin at the V2-receptor, tolvaptan has been shown in preclinical trials to decrease cyst-cell proliferation and fluid secretion, ultimately reducing cyst growth.[iii] In an initial phase 3 trial, tolvaptan demonstrated a reduction in kidney growth and a slower decline in kidney function, measured as the decline in estimated GFR (glomerular filtration rate), compared with placebo in patients with relatively preserved kidney function.[iv] In a subsequent phase 3 trial that included patients at later stages of ADPKD, a slower decline in estimated GFR for patients taking tolvaptan was again observed compared with patients taking placebo.[v] Through monthly blood monitoring, this subsequent trial confirmed originally observed frequency of liver abnormalities. With early enough detection, confirmation and discontinuation, progression to more serious liver injury was avoided in this trial. Tolvaptan is approved for the treatment of adult patients with ADPKD in Japan, the EU, Canada, South Korea, Switzerland, Hong Kong and Australia (see local prescribing information for specific indications in each country). No treatment for ADPKD is currently approved for use in the U.S. Tolvaptan is an investigational agent currently under review by the FDA. About Otsuka Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion in 2016. All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on Twitter at @OtsukaUS. Contacts for media Otsuka in Japan Jeffrey Gilbert (Outside the US)Leader, Pharmaceutical PR Otsuka Pharmaceutical, Co., Ltd. [email protected] Phone: +81 3 6361 7379 Otsuka in the US Jill RomanDirector, External Communications,Otsuka America Pharmaceutical, Inc. 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