(Reuters) – The U.S. Food and Drug Administration (FDA) on Wednesday approved GSK Plc’s drug to treat anemia in some patients with chronic kidney disease.
The FDA approved Jesduvroq tablets as the first oral treatment for anemia caused by chronic kidney disease for adults who have been on dialysis for at least four months.
The treatment is not approved for patients who are not on dialysis because its safety has not been established in that population, the FDA said.
The health agency’s decision comes after its advisory committee recommended the treatment for some kidney patients in October.
The approval for the anemia drug also makes it GSK’s first since it spun off its consumer health business, home to Sensodyne toothpaste and Advil pain killers, last year.
(Reporting by Khushi Mandowara and Sriparna Roy in Bengaluru; Editing by Shailesh Kuber and Anil D’Silva)
