FDA approves Roche's Rituxan

Monday, 30. September 2019 07:51

The United States Food and Drug Administration approved Roche Holding AG's Rituxan for the treatment of potentially life-threatening diseases affecting small and medium-sized blood vessels, the company announced on Monday. The approval is the first pediatric indication for the medication, which is used for the treatment of autoimmune conditions.

"Rituxan is now approved as the first and only medicine for pediatric patients living with GPA and MPA, two potentially life-threatening blood vessel disorders which are rare in children. Today's approval is a result of our ongoing commitment to working with the FDA to develop medicines for pediatric patients with rare diseases where there is a serious unmet need," Roche's chief medical officer Sandra Horning said in the press release.

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Breaking the News / MD