Genentech: FDA Grants Priority Review For Rituxan For Pemphigus Vulgaris

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(RTTNews.com) - Genentech, a member of the Roche Group (ROG.SW, RO.SW), announced the U.S. FDA has accepted the company's Supplemental Biologics License Application and granted Priority Review for the use of Rituxan (rituximab) for the treatment of pemphigus vulgaris. The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of pemphigus vulgaris.

The sBLA submission is based on data from a Roche-supported randomized trial conducted in France which evaluated Rituxan plus a tapering regimen of low dose oral corticosteroid treatment compared to a standard dose of CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus.

Read the original article on RTTNews (http://www.rttnews.com/2862349/genentech-fda-grants-priority-review-for-rituxan-for-pemphigus-vulgaris.aspx)

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Referenced Symbols: ROG

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