Genentech, a member of Roche (RHHBY), announced that the FDA has accepted the company’s supplemental biologics license application for Gazyva for the treatment of lupus nephritis. The filing acceptance is based on positive results from the Phase III REGENCY study, which showed improved complete renal response with Gazyva plus standard therapy compared with standard therapy alone. The FDA is expected to make a decision on approval by October.
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