The filing was based on Phase III clinical trial results of the drug candidate tolvaptan, a selective V2 vasopressin receptor antagonist.
Otsuka Pharmaceutical president and representative director Dr. Taro Iwamoto said the NDA submission represents an important milestone for Otsuka and for patients with ADPKD.
"Tolvaptan was discovered by Otsuka in Japan, and, if approved by the FDA, would become the first pharmaceutical therapy for patients who suffer from ADPKD," Iwamoto added.
Tolvaptan is believed to reduce the development and growth of kidney cysts thereby slowing down the ADPKD progression.
Development and growth of kidney cysts are characteristic of the disease coupled with pain, hypertension, decreased kidney function and ultimately, kidney failure.