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June 26, 2020 07:37 ET | Source: Novartis International AG

Novartis Cosentyx® gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile

EMA CHMP positive opinion paves way for Cosentyx® to become a first-line systemic treatment in pediatric psoriasis CHMP opinion based on two Phase III studies showing Cosentyx provides fast and strong...
June 26, 2020 07:21 ET | Source: Novartis International AG

Novartis receives positive CHMP opinion for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps

If approved, Xolair® (omalizumab) will provide patients who have severe chronic rhinosinusitis with nasal polyps, not adequately controlled by intranasal corticosteroids, with the first...
June 05, 2020 01:15 ET | Source: Novartis International AG

Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma

Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving...
June 04, 2020 01:15 ET | Source: Novartis International AG

Novartis PREVENT data show Cosentyx® helps patients realize early and lasting relief in axial spondyloarthritis

Phase III PREVENT data show Cosentyx® 150 mg provided significant and sustained improvement in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) up to Week 521 nr-axSpA is the...
May 27, 2020 01:15 ET | Source: Novartis International AG

Novartis announces new late-breaking ofatumumab data at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS)

Rapid and profound depletion of B-cells contributed to a halt in disease activity in RMS patients1 A post hoc analysis showed 47.0% and 87.8% of patients treated with ofatumumab achieved no...
April 29, 2020 01:15 ET | Source: Novartis International AG

Novartis Cosentyx® gains fourth indication in EU with first-in-class approval in axial spondyloarthritis spectrum

Cosentyx® is the first fully-human IL-17A inhibitor indicated for patients in Europe with non-radiographic axial spondyloarthritis (nr-axSpA), which forms part of the axial spondyloarthritis (axSpA)...
April 21, 2020 01:15 ET | Source: Novartis International AG

Novartis announces new Mayzent® (siponimod) data show sustained effect in delaying disability for up to five years in patients with secondary progressive multiple sclerosis (SPMS)

New long-term data from EXPAND show patients with SPMS continuously treated with Mayzent® (siponimod) experienced lower risk of disability progression and cognitive decline than patients who delayed...
March 27, 2020 09:02 ET | Source: Novartis International AG

Novartis Cosentyx® gains positive CHMP opinion for new indication in the axial spondyloarthritis spectrum

EMA CHMP positive opinion in non-radiographic axial spondyloarthritis (nr-axSpA) paves way for fourth indication in Europe, and is based on Phase III PREVENT data1 If approved, Cosentyx would become...
February 24, 2020 01:15 ET | Source: Novartis International AG

Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as...