SOUTH SAN FRANCISCO (dpa-AFX) - Roche Holding AG (RHHBY.PK), Friday announced the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has recommended the approval of Gazyva/Gazyvaro in combination with mycophenolate mofetil for the treatment of lupus nephritis in adults.
The recommendation is backed by findings from the phase II NOBILITY and phase III REGENCY studies, which demonstrated that nearly half of the participants on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response compared to 33.1 percent on standard therapy alone.
Moreover, the findings revealed a statistically significant and clinically meaningful reduction of corticosteroid use, and an improvement in proteinuric response, all signalling improved disease control.
The company expects to receive a final decision from the European Commission in the near future.
On the other side, the U.S. Food and Drug Administration is estimated to make a final decision this year on the supplemental Biologics License Application, filed by the company using data from the phase III REGENCY study.
On October 15, Roche's stock closed at $44.67, up 0.43 percent on the OTC Markets.
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