Novartis receives complete response letter from U.S. FDA for inclisiran

  • The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related conditions
  • No onsite inspection was conducted of the single third-party facility in question. If a facility inspection is needed, FDA will define an approach once safe travel may resume based on public health need and other factors
  • Novartis will work with FDA and the third-party manufacturing …
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Novartis builds on commitment to addressing need in neuropsychiatric disorders with Cadent Therapeutics acquisition

  • The agreement includes two clinical stage molecules for schizophrenia and movement disorders and MIJ821, a clinical stage molecule previously licensed exclusively by Novartis for addressing treatment-resistant depression.
  • The deal builds on Novartis expertise in neuroscience and advances the company’s development of potential neuropsychiatric medicines.
  • The planned acquisition reflects the Novartis commitment to reimagining neuroscience by bringing potentially transformative therapies to patients who suffer from severe, …
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Novartis investigational oral therapy iptacopan (LNP023) receives FDA Breakthrough Therapy Designation for PNH and Rare Pediatric Disease Designation for C3G

  • Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood disorder, resulting in debilitating symptoms that can impact patients’ quality of life1–3

  • C3 glomerulopathy (C3G) is a rare renal disease, affecting young patients with a poor prognosis and significant unmet need4-5

  • With potential to be the first oral treatment for a range of complement-driven diseases, complement factor B inhibitor iptacopan targets the underlying cause of these conditions through its action on the …
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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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