SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RO.SW, ROG.SW) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Gazyva/Gazyvaro as an add-on therapy for the treatment of adult patients with moderate-to-severe, active, autoantibody-positive systemic lupus erythematosus despite standard therapy. The positive recommendation is based on results from the phase III ALLEGORY study. A final decision from the European Commission is expected in the near future.
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said: 'This positive CHMP recommendation brings Gazyva/Gazyvaro a step closer to offering people with SLE a new option that may achieve meaningful and sustained disease control.'
Roche shares are trading at 403.70 francs on SIX Swiss Exchange, down 0.69%.
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