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Genentech: Phase III PEMPHIX Study With Rituxan Meets Primary End Point

Genentech, affiliated to Swiss drug major Roche Group (RHHBY), announced Thursday that the Phase III PEMPHIX Study with Rituxan (Rituximab) in patients with Pemphigus Vulgaris or PV met the primary and secondary endpoints.

The study evaluated the efficacy and safety of Rituxan compared to mycophenolate mofetil or MMF that is accepted as standard of care.

Rituxan demonstrated that it is superior to standard of care in achieving sustained remission in adults with moderate to severe PV.

Genentech will present the complete data from the PEMPHIX study at an upcoming medical congress. The results will be submited to health authorities around the world, including the U.S. Food and Drug Administration.

In June 2018, Rituxan became the first and only biologic therapy approved by the FDA for the treatment of PV based on results from the Ritux 3 clinical trial. The latest PEMPHIX trial provided additional clinical evidence on the effectiveness of Rituxan for PV.

PV is a rare, serious and potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

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