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Roche's Gazyva showed strong results in treating lupus, meeting key goals in a major trial.
Roche reported positive Phase III results from the ALLEGORY trial, showing that adding Gazyva (obinutuzumab) to standard therapy significantly reduced disease activity in adults with systemic lupus erythematosus (SLE).
The drug met its primary endpoint, with more patients achieving a four-point improvement in the SRI-4 score at 52 weeks, and also met all key secondary endpoints, including reduced flares and steroid use.
No new safety concerns were found.
If approved, Gazyva would be the first anti-CD20 therapy specifically for SLE, targeting B cells involved in disease inflammation.
The company plans to submit data to global regulators.
El Gazyva de Roche mostró fuertes resultados en el tratamiento del lupus, cumpliendo objetivos clave en un ensayo importante.