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Ad hoc release / Jan 29, 2021

Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis

Kesimpta is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in MS1CHMP opinion is…
Press release / Jul 21, 2017

Novartis receives positive CHMP opinion for Rydapt® (midostaurin) for newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM)

Recommendation based on largest trial in FLT3-mutated AML to date, showing 23% reduction in the risk of death with Rydapt treatment regimen[1] If approved, Rydapt would represent the first…
Press release / Sep 01, 2015

Novartis receives EU approval for Tafinlar® and Mekinist®, first combination approved for patients with aggressive form of melanoma

Approval based on two Phase III studies demonstrating statistically significant overall survival benefit with combination therapy vs BRAF inhibitor monotherapy Targeted combination offers…
Ad hoc release / Oct 16, 2020

Novartis receives positive CHMP opinion for Leqvio®* (inclisiran), a potential first-in-class siRNA for the treatment of high cholesterol

If approved, inclisiran will be the first and only small interfering RNA (siRNA) in Europe for patients with hypercholesterolemia or mixed dyslipidemia1Cardiovascular disease (CVD) claims 3.9…
Ad hoc release / May 24, 2019

AveXis receives FDA approval for Zolgensma®, the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA)

SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis and, when left untreated in its most severe form, permanent ventilation or death for most patients by age 2[1],[2…
Press release / Apr 07, 2016

Novartis receives EU approval for Revolade® as first-in-class therapy for children aged 1 year and above with chronic ITP

EU approval of Revolade expands treatment options for pediatric patients aged 1 year and above with chronic ITP who have not responded to other therapies Two formulations approved: once-daily…
Press release / Aug 30, 2017

Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice

First-in-class therapy showed an 83% (52/63) overall remission rate in this patient population with limited treatment options and historically poor outcomes [1],[2]. Novel approach to cancer…
Press release / May 01, 2020

Novartis receives CHMP positive opinion for Enerzair® Breezhaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma

CHMP positive opinion advances efforts to provide first-in-class LABA/LAMA/ICS combination for patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment in the EU. Digital…
Press release / Aug 25, 2023

Sandoz receives FDA approval for Tyruko® (natalizumab-sztn), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis

Biosimilar Tyruko® approved for all indications of reference medicine, with same dosing and administration schedule Sandoz continues to expand access to much-needed medications for patients…
Ad hoc release / Jul 21, 2020

Novartis delivered strong H1 performance. FY 2020 guidance confirmed at higher end for core operating income and lower end for sales.

Due to COVID-19 first half results are more representative of underlying performance than Q2, sales growth of 6% (cc1, +3% USD) and core¹ operating income growth of 19% (cc, +14% USD):…

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