Novartis ligelizumab (QGE031) receives FDA Breakthrough Therapy designation for patients with chronic spontaneous urticaria (CSU)

  • Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria (CSU) in patients with an inadequate response to H1-antihistamines1
     
  • Currently there are limited approved therapies for patients with CSU, also known as chronic idiopathic urticaria (CIU)
     
  • Breakthrough Therapy designation suggests ligelizumab has the potential to provide a substantial benefit over existing available treatments
     
  • U.S. regulatory filing in CSU is anticipated in 2022 …
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Novartis expands Oncology pipeline with in-licensing of tislelizumab from BeiGene

  • Agreement expands Novartis Oncology portfolio, adding late-stage PD-1 for monotherapy and potential proprietary PD-1 combinations, driving mid- and long-term growth

  • Novartis secures development and commercialization rights in North America, Europe, and Japan

  • Accelerates Novartis immuno-oncology combination strategy with multiple potential tislelizumab plus Novartis therapy combinations

  • Tislelizumab already approved for patients with classical Hodgkin’s lymphoma and metastatic urothelial …
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Turning the sound up on patient voices in lung cancer research and development

For Pierre-Alexis Ruffié, managing clinical trials at Novartis is personal. “I don’t usually share this, but I was a cancer patient when I was younger. I had surgery and chemotherapy, so I know how it feels to be on the other side,” says Ruffié, who serves as Associate Global Trial Director in Oncology at Novartis. “You’re always wondering, ‘What are they going to find? Is it going to be worse?’ My own experience makes me pay close attention to the feelings and experiences of the people participating in our trials.”

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AI Nurse evolving for health failure patients in China

Dozens of improved versions of our new digital platform for heart failure disease management in China have been developed since roll-out a few months ago.

Why? Because the digital product team in Novartis China has quickly learned from user feedback – evolved its approach to Health Care Professionals (HCPs) – and rapidly developed product enhancements.

Realizing the onboarding experience for patients was too complicated in a busy hospital environment – and patients were struggling to manage their condition in lockdown during the COVID-19 pandemic, the AI Nurse …

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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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