U.S. FDA approves Travere Therapeutics kidney disorder drug (updated)

Calliditas Therapeutics AB

17/02/2023 21:30

(Adds background)
       Feb 17 (Reuters) - Travere Therapeutics  TVTX.O  said on
Friday the U.S. health regulator has granted accelerated
approval to its drug to treat a type of chronic kidney disease,
called IgAN, in adults with a high risk of advancing to kidney
failure. 
    The drug, with the brand name Filspari, comes with a boxed
warning for inflammation in liver and birth defects.
    The approval pits Filspari against Calliditas Therapeutics'
 CALTX.ST  Tarpeyo, which was greenlit by the U.S. Food and Drug
Administration in December 2021.
    IgA nephropathy (IgAN), also called Berger's disease, occurs
when immunoglobulin A antibodies, proteins made by the immune
system to protect the body, build up in the kidneys, damaging
tissues and leaking blood and protein into urine. 
    The tissue damage affects the filtering ability of the
kidneys, and eventually progresses to end-stage kidney failure.
Analysts estimate that about 150,000 patients suffer from this
condition in the U.S.
 (Reporting by Sriparna Roy, Khushi Mandowara and Nandhini
Srinivasan in Bengaluru; Editing by Krishna Chandra Eluri)
 ((Sriparna.Roy@thomsonreuters.com;))