Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF

  • The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF)
  • Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of chronic heart failure: HFpEF and HFrEF; and the only chronic heart failure treatment studied in both conditions against active comparators1,2
  • HFpEF patients currently have no approved treatment options and …
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Novartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edema

  • In Phase III KESTREL study, Beovu (brolucizumab 6 mg) achieved its primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at year one (week 52)1

  • In a secondary endpoint, more than half of Beovu patients in the 6 mg arm were maintained on a three-month dosing interval through year one, following the loading phase1

  • Significant improvement with Beovu 6 mg in change of central subfield thickness (CST) from baseline over …
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The RUXCOVID clinical trial

The global pandemic has left virtually no part of the world untouched, and moved our industry to collaborate like never before, and leverage our expertise and resources to support the global response to the COVID-19 pandemic. The RUXCOVID clinical trial is a testament to the Novartis commitment to contribute to these efforts.

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Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19

  • Phase III study did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care)1
  • Detailed results will be submitted for publication to support scientific understanding of JAK inhibition in COVID-19 and inform ongoing research
  • Novartis commitment to address COVID-19 pandemic remains strong with multiple research collaboration initiatives ongoing

Basel, December 14, 2020 …

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Novartis receives EU approval for Leqvio®* (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year**

  • Leqvio® (inclisiran) is the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol (LDL-C) lowering treatment in Europe1-3
  • Cardiovascular disease causes 3.9 million deaths annually in Europe, and 80% of high-risk patients do not reach guideline-recommended LDL-C targets despite the widespread use of statins4-7
  • Approval …
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Novartis Kisqali® data demonstrate superior benefit across main intrinsic subtypes in metastatic breast cancer

  • Findings presented at SABCS from largest intrinsic subtype analysis show Kisqali is unique among CDK4/6 inhibitors, delivers consistent efficacy across main HR+/HER2- intrinsic subtypes1
  • Benefit seen even in patients with the endocrine-resistant HER2-enriched subtype, who face poor prognosis with …
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Novartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancer

  •  MONALEESA-7 median overall survival (OS) results reinforce Kisqali as the CDK4/6 inhibitor with unrivaled OS evidence1

  • Kisqali plus endocrine therapy had a median OS of nearly five years (58.7 months), the longest ever reported for premenopausal women with HR+/HER2- metastatic breast cancer (MBC), after a median of 53.5 months follow-up1

  • Kisqali …
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Novartis investigational STAMP inhibitor asciminib (ABL001) shows superior MMR rate to Bosulif®* in chronic myeloid leukemia trial

  • At 24 weeks, asciminib nearly doubled the major molecular response (MMR) rate compared to Bosulif® (bosutinib)*, in patients resistant to, or intolerant of, at least two prior tyrosine kinase inhibitor (TKI) therapies1

  • Despite advances in chronic myeloid leukemia (CML) care, many patients are at risk of disease …
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Novartis analyses confirm benefit of Kymriah® with clinically meaningful rates of complete response seen in patients with certain advanced lymphomas

  • Interim analysis from the investigational ELARA study shows, 65% of patients with r/r follicular lymphoma evaluated for efficacy achieved a complete response and the overall response rate was 83%1
  • Longer-term median follow-up of 40 months from the JULIET study showed a 33% two-year progression-free survival rate in patients with r/r DLBCL2
  • Both ELARA and JULIET trials reaffirm safety profile of Kymriah with no new short- or long-term safety signals identified

Basel, December 5, 2020 …

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Novartis announces first data from REACH3 trial showing Jakavi® (ruxolitinib) significantly improved outcomes in patients with steroid-resistant/dependent chronic GvHD

  • Results of REACH3 trial also demonstrate significant improvements in failure-free survival (FFS) and patient-reported symptoms1
  • Chronic graft-versus-host disease (GvHD) is a life-threatening complication of stem cell transplants and half of patients become steroid refractory/dependent2,3
  • Findings from the study were presented …
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