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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