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  • Ultomiris under review as myasthenia gravis Tx in Korea
  • by Eo, Yun-Ho | translator Kim, Jung-Ju | Jun 16, 2023 05:54am
Applied for approval to the MFDS...under review
Improved MG-ADL through CHAMPION-MG study
The paroxysmal nocturnal hemoglobinuria (PNH) treatment ¡®Ultomiris¡¯ is seeking to secure an indication for myasthenia gravis (gMC) in Korea.

According to industry sources, AstraZeneca Korea submitted an application to the Ministry of Food and Drug Safety and is being reviewed for the indication to treat adults with generalized myasthenia gravis who are anti-acetylcholine receptor (AChR) antibody-positive.

Ultomiris¡¯s myasthenia gravis indication was approved by the US FDA in April 2022, and by the European Commission in September of the same year.

Myasthenia gravis is a rare, chronic, autoimmune neuromuscular disease that causes patients to lose muscle function and cause severe weakness. AChR antibody-pos
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