FDA approves GSK anaemia drug

The US regulator has given the green light to a GSK treatment for anaemia in patients with chronic kidney disease, the medicines and vaccines group confirmed on Thursday.

The FTSE 100 firm said the US Food and Drug Administration had approved Jesduvroq, a once-a-day oral treatment, for adults who have been receiving dialysis for at least four months.

GSK called Jesduvroq the "first innovative medicine for anaemia treatment in over 30 years", adding that chronic kidney disease affected currently around 700m patients worldwide. An estimated one in seven will develop anaemia.

Tony Wood, GSK chief scientific officer, said: "Over the last several decades there has been little innovation in anaemia of CKD. We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options."

A marketing application for Jesduvroq has been lodged with the European Medicines Agency, with a regulatory decision expected in the first half of 2023. It has already been approved for use in Japan.

The FDA based its assessment on results from GSK’s Ascend-D trial, which assessed the efficacy and safety of the drug in treating anaemia in CKD patients.