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Press release / Mar 13, 2017

Novartis Kisqali® (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor

Approved based on a first-line Phase III trial that met its primary endpoint of progression-free survival (PFS) at interim analysis due to superior efficacy compared to letrozole alone[1] …
Press release / Oct 08, 2016

Novartis breakthrough therapy LEE011 plus letrozole demonstrates superior progression-free survival as first-line treatment for HR+/HER2- advanced breast cancer compared to a standard of care

LEE011 (ribociclib) plus letrozole reduced the risk of progression or death by 44% over letrozole alone, significantly extending progression-free survival (PFS) across all patient subgroups…
Press release / Oct 01, 2016

Novartis late-breaking data show Cosentyx delivers high and long-lasting skin clearance over 4 years for psoriasis patients

Cosentyx® delivers long-lasting clear or almost clear skin (PASI 90 to PASI 100) in the vast majority of patients and continues to show a favorable safety profile over 4 years[1] New data show…
Press release / Jan 04, 2018

Novartis drug Promacta® receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)

Data supporting designation showed over half of treatment-naïve SAA patients achieved complete response with Promacta when given with standard immunosuppressive therapy, with overall response rate of…
Ad hoc release / May 18, 2018

Novartis and Amgen announce FDA approval of Aimovig(TM) (erenumab), a novel treatment developed specifically for migraine prevention

Migraine is a severe neurologic disease that profoundly impacts millions of patients in the United States Aimovig is the first and only FDA-approved treatment to block the calcitonin gene-…
Press release / May 12, 2018

Novartis announces FDA approval of Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis

New approval for Gilenya (fingolimod) addresses strong unmet need for younger patients, who often experience more frequent relapses than adults with multiple sclerosis (MS)[1] In a…
Press release / Jul 06, 2017

Novartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasis

Label update includes 52 week data from CLEAR study demonstrating long-term superiority of Cosentyx® versus Stelara® in psoriasis [1],[2] Update also includes use of Cosentyx in moderate-to…
Press release / Jan 19, 2015

Novartis Cosentyx(TM) is the first IL-17 inhibitor to receive EU approval for first-line treatment of moderate-to-severe psoriasis patients

Cosentyx is the only biologic that can be used as first-line systemic therapy in the treatment of psoriasis and as an alternative to treatments that have significant side effects[1]; all other…
Ad hoc release / Apr 09, 2018

Novartis enters agreement to acquire AveXis Inc. for USD 8.7 bn to transform care in SMA and expand position as a gene therapy and Neuroscience leader

AveXis lead product candidate, AVXS-101, has potential to be first-ever one-time gene replacement therapy for spinal muscular atrophy (SMA), a disease which results in early death or lifelong…
Press release / Feb 08, 2018

Novartis receives FDA approval for Cosentyx® label update to include moderate-to-severe scalp psoriasis

US label updated to include Cosentyx® (secukinumab) data in moderate-to-severe scalp psoriasis[1] - one of the difficult-to-treat types of psoriasis[2] Approximately half of all 125 million…

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