AstraZeneca suspends supply of low-concentration Ultomiris in Korea

AstraZeneca has suspended the supply of a low-concentration batch of its C5 complement inhibitor Ultomiris (ravulizumab) in Korea

The Ministry of Food and Drug Safety (MFDS) said that AstraZeneca Korea reported the suspension of Ultomiris supply on Tuesday.

AstraZeneca Korea has stopped supplying the product since June 30, 2023, and has no plans to import it. The company reported that the decision to suspend imports was due to circumstances at its headquarters.

Ultomiris is used for patients with rare diseases and was initially approved in Korea in May 2020 at a dose of 300 mg/30 mL. Later, a highly concentrated formulation, Ultomiris 100mg/mL, won approval separately. The product whose supply has been stopped this time is a 300mg/30 mL dose.

Alexion Pharmaceuticals, a U.S. company, developed Ultomiris. It is approved in Korea for treating paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).

When it won initial approval, Handok was responsible for domestic supply, but since Alexion's merger with AstraZeneca in February 2023, AstraZeneca Korea has been responsible for domestic sales.

According to the MFDS, AstraZeneca Korea believes that patients using the low-concentration Ultomiris have switched to the higher-concentration formulation and that the supply interruption will not have a significant impact on patient care.