Novartis sabatolimab receives orphan drug designation from the European Commission for myelodysplastic syndromes

Novartis announced today that the European Commission (EC) has granted orphan drug designation to sabatolimab (MBG453) for the treatment of myelodysplastic syndromes (MDS), based on clinical data showing a high rate of responses in patients with high-risk MDS who were treated with sabatolimab in combination with hypomethylating agents (HMAs). The decision follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA)1.

  • MDS are a group of rare and often underdiagnosed blood cancers characterized by two major …
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Novartis Leqvio®* (inclisiran) analyses show effective and sustained LDL-C reduction in two sub-populations of patients with ASCVD

  • Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly** Leqvio® (inclisiran) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) with established cerebrovascular disease (CeVD)1 and polyvascular disease (PVD)2
  • Overall, Leqvio was well-tolerated, with a safety profile similar to placebo and consistent with the overall pooled population from the combined trials1 …
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Novartis presents important overall survival and quality-of-life results across solid tumor portfolio, among other key data at ESMO

  • New Kisqali® (ribociclib)* overall survival (OS) results from MONALEESA-2 trial in HR+/HER2− advanced breast cancer patients in the first-line setting

  • Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer

  • Data supporting upcoming regulatory filings for tislelizumab in people with squamous and non-squamous non-small cell …
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FDA accelerates review of Novartis STAMP inhibitor asciminib (ABL001) for patients with chronic myeloid leukemia (CML)

Novartis today announced that the US Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application (NDA) for asciminib (ABL001) in chronic myeloid leukemia (CML), following its submission under the FDA’s Real-Time Oncology Review (RTOR) program. Priority Review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions, as determined by the FDA1. This designation could shorten the FDA review period to eight months compared to the 12 months …

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Novartis provides update on BELINDA study investigating Kymriah® as second-line treatment in aggressive B-cell non-Hodgkin lymphoma

  • Phase III BELINDA study did not meet primary endpoint of event-free survival for patients with aggressive B-cell non-Hodgkin lymphoma who had primary refractory disease or who relapsed within 12 months of first-line treatment
  • Novartis CAR-T innovation continues to accelerate development of next-generation platform with improved CAR-T cellular characteristics, high speed, lower cost of goods sold (COGS) and advancement of clinical research into new indications and targets; early clinical data anticipated at upcoming medical meeting
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Novartis secures new approval in China for Cosentyx® (secukinumab) in pediatric psoriasis

  • China National Medical Products Administration (NMPA) approval reinforces that Cosentyx® (secukinumab) is safe and effective for children and adults with psoriasis
  • Moderate-to-severe plaque psoriasis affects more than 350,000 children worldwide1, with the physical and psychological burden disrupting important formative years2
  • Cosentyx is a proven treatment, supported by long-term five-year sustained efficacy and safety data across several inflammatory …
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Novartis announces positive results from Phase III trials of Beovu® in diabetic macular edema, including dosing intervals up to 16 weeks

  • Results from year two of the pivotal Phase III KITE clinical trial reaffirmed visual acuity gains and fluid reduction findings as well as safety profile from year one1,2
  • In key fluid-related secondary endpoints from KITE at year two, Beovu® (brolucizumab) 6 mg demonstrated greater reductions in central subfield thickness, and fewer patients had intraretinal and/or subretinal fluid versus aflibercept1
  • A majority of patients who …
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Asia Pacific Patient Innovation Summit examines capability building gaps of Patient Organizations

The Asia Pacific Patient Innovation Summit (APPIS) has published its first whitepaper that examines the regional landscape for patient organizations and explores existing capability building gaps. The patient community-led report, ‘Partnering with patient organizations to address the unmet needs of patient communities in the Asia Pacific region and beyond’, aims to enable a greater understanding and recognition of the seminal role of patient organizations and the patient voice in shaping the future of healthcare, while providing a series of recommendations for patient groups: 

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Novartis announces lift of partial clinical trial hold and plans to initiate a new, pivotal Phase 3 study of intrathecal OAV-101 in older patients with SMA

Ad hoc announcement pursuant to Art. 53 LR

  • FDA concluded that OAV-101 intrathecal (IT) clinical program may proceed based on data from nonclinical toxicology study
  • New Phase 3 STEER study will evaluate efficacy, safety, and tolerability of OAV-101 IT in treatment-naïve patients with SMA Type 2 aged between 2 and 18 years old, the first to study gene therapy in this patient population
  • STEER will build upon the OAV-101 IT STRONG study which demonstrated significant increases in HFMSE scores and a …
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