Brief: Tricida Receives Complete Response Letter From FDA For Veverimer To Treat Kidney Disease

Tricida

24/08/2020 13:42

Aug 24 (Reuters) - Tricida Inc  TCDA.O :
    * TRICIDA RECEIVES COMPLETE RESPONSE LETTER FROM THE FDA FOR
ITS
NEW DRUG APPLICATION FOR VEVERIMER FOR THE TREATMENT OF
METABOLIC ACIDOSIS AND SLOWING OF KIDNEY DISEASE PROGRESSION IN
PATIENTS WITH METABOLIC ACIDOSIS ASSOCIATED WITH CKD
    * TRICIDA INC - FDA IS SEEKING ADDITIONAL DATA BEYOND
TRCA-301 AND
TRCA-301E TRIALS REGARDING MAGNITUDE AND DURABILITY OF TREATMENT
EFFECT OF VEVERIMER
    * TRICIDA INC - THERE WERE NO SAFETY, CLINICAL
PHARMACOLOGY/BIOPHARMACEUTICS, CMC OR NON-CLINICAL ISSUES
IDENTIFIED IN CRL
    * TRICIDA -  FDA INDICATED IT IS WILLING TO MEET TO DISCUSS
OPTIONS FOR OBTAINING APPROVAL, INCLUDING UNDER ACCELERATED
APPROVAL PROGRAM FOR VEVERIMER
    * TRICIDA INC - PLANS TO REQUEST A TYPE A MEETING WITH FDA
IN
COMING WEEKS FOR VEVERIMER
    * TRICIDA INC - BELIEVES THAT IT IS WELL POSITIONED
FINANCIALLY TO
FUND ITS OPERATIONS INTO EARLY 2022

Source text for Eikon:  ID:nBw1T5blVa 
Further company coverage:  TCDA.O 

 ((Reuters.Briefs@thomsonreuters.com;))