FDA offer priority review for Genentech’s Rituxan in children

pharmafile | June 13, 2019 | News story | Research and Development  

The FDA will offer priority review to Genentech’s supplemental biologics-license application (sBLA) application for Rituxan for children with two rare blood vessel disorders.

The Roche subsidiary’s sBLA covers Rituxan’s use in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children two years of age and older.

The FDA offers priority review to drugs that have the might provide significant benefits in the treatments of serious diseases.

Rituxan has in the past been approved for immunological diseases and various forms of cancer. However if approved, the sBLA application would mark the first paediatric indication for the drug.

Louis Goss

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