Kyowa Kirin Korea announced on August 7th that the Ministry of Food and Drug Safety (MFDS) has approved a new 180 µg dosage of the anemia treatment, 'Nesp Prefilled Syringe' (active ingredient: darbepoetin alfa). This high-dose version is intended for patients with chronic kidney disease and those undergoing chemotherapy for cancer.

Nesp, developed by Kyowa Kirin and Amgen, is designed to treat anemia in patients on hemodialysis or peritoneal dialysis, as well as those with chronic kidney disease or cancer undergoing chemotherapy. The drug’s long-acting formulation allows for administration once every one to two weeks for dialysis patients.

Previously, Nesp was approved in dosages of 20 µg, 30 µg, and 60 µg in 2009, followed by 40 µg and 120 µg in 2014. With the recent approval, the available dosages have expanded to six.

The dosage and administration of Nesp vary based on the patient's condition, stage of treatment, and therapy type, including initial dosing, replacement doses, and maintenance therapy. For patients on hemodialysis, the initial dose is typically 20 µg intravenously once a week, with maintenance doses ranging from 15 to 60 µg weekly. If anemia management is maintained, the administration can be adjusted to biweekly injections, with doses ranging from 30 to 120 µg per injection.

However, depending on factors such as the severity of anemia and patient age, higher dosages may be required. The maximum allowable dosage has now been set at 180 µg, addressing the needs of patients who previously required additional doses beyond the 120 µg maximum. The same dosage adjustments apply to patients with peritoneal dialysis and chronic kidney disease.

With the approval of the higher dosage, patients needing the maximum dose can now receive it through a single injection, improving treatment efficiency and patient compliance.

In addition to Nesp, Kyowa Kirin Korea, in collaboration with LG Chem, co-markets other treatments such as 'Regpara' (active ingredient: cinacalcet hydrochloride) for secondary hyperparathyroidism and 'Nephoxil' (active ingredient: ferric citrate hydrate) for hyperphosphatemia.

According to market research firm IQVIA, Nesp's sales in 2023 reached approximately $17.3 million, reflecting an 11.1% increase from $15.8 million in the previous year.