(Reuters) -The U.S. Food and Drug Administration (FDA) on Wednesday approved GSK Plc's drug as the first oral treatment for anemia caused by chronic kidney disease in adults who have been on dialysis for at least four months.
The drug Jesduvroq comes with the boxed warning for increased thrombotic vascular events, including death, heart attack, stroke, and blood clots in the lungs, legs, or dialysis access site. The warnings and precautions also include a risk of hospitalization for heart failure, worsening increase of blood pressure, stomach erosions, and gastrointestinal bleeding.
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 approval makes it GSK's first since the company spun-off its consumer health business - home to Sensodyne toothpaste and Advil pain killers - last year.
The health agency's decision also comes after its advisory committee recommended the treatment for some kidney patients in October.
The wholesale acquisition cost has not yet been set for Jesduvroq, GSK told Reuters. "As 87% of dialysis patients are on Medicare, we are in the process of submitting the required documentation with Centers for Medicare & Medicaid Services (CMS) to help ensure timely reimbursement and patient access to Jesduvroq."
This is the first drug in the HIF-PH inhibitor class to win U.S. FDA approval, as similar drugs developed by FibroGen and AstraZeneca, and Akebia Therapeutics have failed to secure the regulator's nod earlier.
HIF-PH inhibitors are a class of oral drugs designed to boost production of red blood cells by mimicking the body's response at high altitudes, where a lack of oxygen leads to increase in red cell numbers and hemoglobin concentration.
(Reporting by Khushi Mandowara and Sriparna Roy in Bengaluru; Editing by Shailesh Kuber, Anil D'Silva, and Uttaresh.V)