US FDA approves Ardelyx's kidney disease-related drug (updated)

Ardelyx

18/10/2023 24:24

(adds background in paragraph 2-4;  details from the statement
in paragraph 5)
       Oct 17 (Reuters) - The U.S. Food and Drug Administration
(FDA) has approved  Ardelyx's  ARDX.O  drug to treat high
phosphate levels in patients with chronic kidney disease (CKD),
the company said on Tuesday, more than two years after it was
initially rejected.
    The drug, branded as Xphozah, was approved to treat
hyperphosphatemia, a condition resulting in an abnormally
elevated level of phosphorus in the blood.
    Excess phosphorus can remove calcium from bones and other
parts of the body, which in turn can cause brittle bones, joint
pain, muscle cramps and itchy skin.
    The FDA has approved the drug for use in patients who have
had an inadequate response or intolerance to phosphate binder
therapies, the current standard-of-care treatment for the
condition.
    The company said a commercial launch for the drug is
underway, adding that it expects to make the drug available in
November.
    

 (Reporting by Kanjyik Ghosh, Mariam Sunny, Khushi Mandowara and
Leroy Leo in Bengaluru; Editing by Shinjini Ganguli and Devika
Syamnath)
 ((Mariam.ESunny@thomsonreuters.com;))