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Press release / Oct 30, 2017

Novartis to present first of its kind evidence for Cosentyx® on potential to maintain mobility in patients with AS and PsA

Long-term 4-year data in ankylosing spondylitis (AS) and 24-weeks data in psoriatic arthritis (PsA) to be presented at the 2017 ACR/ARHP Annual Meeting[1],[2] Structural disease progression is a…
Press release / Jul 24, 2020

Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease

If approved, Adakveo would be the first targeted sickle cell disease therapy available for use in Europe CHMP opinion supported by data showing Adakveo significantly reduced the rate of vaso-…
Press release / Feb 08, 2021

Novartis receives FDA Breakthrough Therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukemia

Designation in patients with chronic myeloid leukemia (CML) resistant or intolerant to prior treatments based on positive data from pivotal Phase III ASCEMBL trial evaluating asciminib, an…
Press release / Jun 21, 2017

Novartis achieves important regulatory milestone for AMG 334 (erenumab) in migraine prevention with EMA filing acceptance

AMG 334 (erenumab) is the first anti-CGRP monoclonal antibody developed for migraine prevention to receive EMA regulatory filing acceptance Filing is supported by a comprehensive clinical…
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…
Press release / Jun 26, 2020

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 anti-…
Press release / Mar 17, 2015

Novartis receives EU approval for Jakavi® in polycythemia vera, first targeted therapy approved for patients with this rare blood cancer

Jakavi® (ruxolitinib) approved by the European Commission for adult patients with polycythemia vera (PV) resistant to or intolerant of hydroxyurea PV is a rare blood cancer associated with…
Ad hoc release / Jun 01, 2018

Novartis receives positive CHMP opinion for Aimovig® (erenumab) for the prevention of migraine

If approved, Aimovig®(erenumab) is expected to be the first and only available therapy designed specifically for migraine prevention in the EU Positive opinion based on robust data package…
Press release / Jan 15, 2016

Novartis receives two new FDA approvals for Cosentyx to treat patients with ankylosing spondylitis and psoriatic arthritis in the US

Cosentyx is the first and only interleukin-17A (IL-17A) inhibitor approved for adult patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) FDA approval for Cosentyx is…
Press release / Apr 02, 2019

Novartis first-in-class Cosentyx® approved in China for psoriasis patients

China Health Authority NMPA approved Cosentyx® (secukinumab) for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy Cosentyx is…

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