FDA Rejects Tricida Chronic Kidney Disease Drug, More Data Needed

Tricida’s bid for speedy approval of a drug for a condition caused by chronic kidney disease has been rejected by the FDA, which is asking for data that may require conducting another clinical trial.

The South San Francisco-based biotech had tested its drug, veverimer, in a Phase 3 study and a follow-on extension study, both of which were part of the application submitted for regulatory review. According to Tricida, the FDA now wants more information about the magnitude and durability of the drug’s effect.

The agency signaled its concerns to Tricida in July, when it sent the company a letter stating... Read more »

Reprints | Share:          

UNDERWRITERS AND PARTNERS

          

          

            
Author: Frank Vinluan

Source : https://xconomy.com/san-francisco/2020/08/25/fda-rejects-tricida-chronic-kidney-disease-drug-more-data-needed/

Date : 2020-08-25T15:26:52.000Z