Otsuka Pharmaceutical Co has suffered a setback after advisors to the US Food and Drug Administration decided not to recommend the Japanese drugmaker’s already-approved tolvaptan for a kidney disorder.
The agency’s Cardiovascular and Renal Drugs Advisory Committee has voted 9 to 6 not to approve tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD). It is a genetic illness characterised by the development of multiple cysts in the kidneys and is the most common inherited kidney disease.
Robert McQuade, chief strategic officer at Otsuka Pharmaceutical Development & Commercialization, said that “while we are disappointed in the committee’s recommendation, we remain committed to providing patients and physicians with a novel treatment for ADPKD”. He added that “we are looking forward to continuing discussions with the FDA to address the panel’s concerns”.
The vote reflected concerns put forward by FDA staffers ahead of the meeting saying that the Otsuka file did not contain enough safety and efficacy data. The FDA accepted the submission for tolvaptan in April and granted the drug priority review status; it has an action date of September 1.
Tolvaptan, which is a vasopressin 2 receptor antagonist, is already approved as Samsca on both sides of the Atlantic to treat hyponatremia.
