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  • Mabthera anticipating indication on pediatric polyangiitis
  • by Eo, Yun-Ho | translator Byun Kyung A | Jan 16, 2020 03:07pm
Submitted indication expansion application last year in Korea, expecting to be processed this year
Phase 3 study demonstrated safety and efficacy in pediatric patients with MPA and GPA
 ¡ã Mabthera
Pharmaceutical industry is expecting anticancer treatment Mabthera to get indicated for treating pediatric patients in Korea.

The industry source reported Roche Korea has submitted an indication expansion application to Ministry of Food and Drug Safety (MFDS) for Mabthera (rituximab) to treat 2-year-old and older pediatric patient with granulomatosis with polyangiitis (GPA) and microscopic plyangiitis (MPA).

The application was for intravenous administration of Mabthera, and it is expected to get cleared within this year considering general processing period.

The two diseases are rare angiitis that flares up inflammation in small vessels and significantly decreases blood volume, resulting in damaging maj
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