FDA Grants Priority Review to Genentech’s Rituxan

Genentech, which falls under the Roche Group (OTCQX:RHHBY) umbrella, has recieved priority review from the US Food and Drug Administration (FDA) for its biologics license application for use of Ritxan together with glucocorticoids to treat granulomatosis with polyangitis and microscopic polyangitis in children aged two and older.

“We are committed to delivering new treatment options for rare diseases, such as pediatric GPA and MPA, for which there are currently no approved medicines,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We will continue to work closely with the FDA to bring Rituxan to children with these two serious and potentially life-threatening diseases.”

Priority Review Designation is granted to medicines that, if approved, the FDA has determined to have the potential to provide significant improvements in the safety or effectiveness of the treatment of a serious disease.

The sBLA was submitted based on data from the PePRS study, a Phase IIa, global, open-label, single-arm study investigating the safety, pharmacodynamics/pharmacokinetics and exploratory efficacy of intravenous Rituxan in 25 patients with severe GPA or MPA between six and 17 years of age.² Treatment with four weekly infusions of Rituxan in combination with a tapering course of oral glucocorticoids was assessed in newly diagnosed or relapsing active GPA or MPA pediatric patients.

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