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www.fdanews.com/articles/177058-gsks-rheumatoid-arthritis-treatment-soars-in-phase-3

GSK’s Rheumatoid Arthritis Treatment Soars in Phase 3

June 14, 2016

GlaxoSmithKline’s rheumatoid arthritis candidate met its co-primary endpoints in a global, pivotal Phase 3 trial.

Subcutaneous sirukumab showed a significant inhibition of progression in adults with moderate to severe active rheumatoid arthritis, reporting less joint erosion and joint space narrowing compared to the placebo.

The therapy also improved 20 percent of RA signs and symptoms in 54.8 percent and 53.5 percent of patients receiving 50 mg and 100 mg of sirukumab, respectively, compared to 26.4 percent for placebo.

GSK expects to submit regulatory applications for sirukumab in the third quarter of 2016.

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