(MENAFN- The Peninsula) Bloomberg
GSK Plc's anemia pill was cleared by US regulators for dialysis patients, adding a potential blockbuster to the drugmaker's stable of new medicines.
The drug, to be sold under the name Jesduvroq, is not approved for patients who are not on dialysis, the US Food and Drug Administration said in a statement on its website.
'Adults with chronic kidney disease on dialysis now have multiple ways to treat their anemia,” said Ann Farrell, director of the FDA's Division of Non-Malignant Hematology. 'Patients can consult with their health-care providers to select the option that is most appropriate.”
The medicine, also known as daprodustat, is a game-changer for patients who currently undergo injections to manage the condition. A panel of FDA advisers voted in October to back the treatment for dialysis patients with anemia from chronic kidney disease, but not in others.
The ruling comes after two other medicines for the same indication, one from AstraZeneca Plc and partner FibroGen Inc. and the other from Akebia Therapeutics Inc., failed to get the regulator's backing. That leaves GSK as the first to enter a market worth an estimated $3 billion in the US, according to Bloomberg Intelligence.
More than 700 million people globally suffer from chronic kidney disease, with one in seven estimated to develop anemia. GSK is hoping daprodustat will be among a new line-up of money-making treatments as it prepares for the loss of a patent on its blockbuster HIV drug dolutegravir later this decade.
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