Brief: Reata Pharmaceuticals Receives CRL From FDA For Potential Kidney Treatment

Reata Pharmaceuticals

25/02/2022 22:39

Feb 25 (Reuters) - Reata Pharmaceuticals Inc  RETA.O :
    * REATA PHARMACEUTICALS RECEIVES COMPLETE RESPONSE LETTER
FROM THE
FDA FOR BARDOXOLONE FOR THE TREATMENT OF PATIENTS WITH CHRONIC
KIDNEY DISEASE CAUSED BY ALPORT SYNDROME
    * REATA PHARMACEUTICALS INC - CRL INDICATES THAT FDA CANNOT
APPROVE BARDOXOLONE METHYL NDA IN ITS PRESENT FORM
    * REATA PHARMACEUTICALS INC - FDA HAS REQUESTED ADDITIONAL
DATA TO
SUPPORT EFFICACY AND SAFETY OF BARDOXOLONE
    * REATA - FDA DOES NOT BELIEVE SUBMITTED DATA SHOWS
BARDOXOLONE IS
EFFECTIVE IN SLOWING LOSS OF KIDNEY FUNCTION IN PATIENTS WITH
ALPORT SYNDROME
    * REATA PHARMACEUTICALS INC -  FDA STATED THAT ISSUES ON
BARDOXOLONE COULD BE RESOLVED BY PROVIDING EVIDENCE OF
EFFECTIVENESS
    * REATA PHARMACEUTICALS INC - FDA STATED THAT CO WOULD NEED
TO
ADDRESS WHETHER BARDOXOLONE HAS A CLINICALLY RELEVANT EFFECT ON
QT INTERVAL
    * REATA PHARMACEUTICALS INC - FDA STATED THAT CO WOULD NEED
TO
SHOW THAT DEMONSTRATED CLINICAL BENEFITS OF BARDOXOLONE OUTWEIGH
ITS RISKS
    * REATA PHARMACEUTICALS INC - WILL CONTINUE TO WORK WITH FDA
TO
CONFIRM OUR NEXT STEPS ON OUR ALPORT SYNDROME PROGRAM

Source text for Eikon:  ID:nBw3Yq2Nna 
Further company coverage:  RETA.O 

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