Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease
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  • Designation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1

  • Distinction expedites development and review of treatments for serious conditions that may demonstrate improvement over standard of care

  • Novartis plans to submit to health authorities globally starting in early 2026
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Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease
arcticnovartis

  • Designation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1

  • Distinction expedites development and review of treatments for serious conditions that may demonstrate improvement over standard of care

  • Novartis plans to submit to health authorities globally starting in early 2026
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Letter to global governments: A call for bold life sciences investment

Letter to global governments: A call for bold life sciences investment
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Novartis to add radioligand therapy manufacturing facility in Winter Park, Florida, fourth in US to serve patients and advance $23 billion investment

Novartis to add radioligand therapy manufacturing facility in Winter Park, Florida, fourth in US to serve patients and advance $23 billion investment
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  • New 35,000-square-foot facility in Winter Park will expand RLT manufacturing footprint to optimize delivery for patients across southeastern US
  • Purpose-built facility will strengthen Novartis RLT manufacturing network alongside existing Indiana, New Jersey, and recently completed California sites
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Novartis and US government reach agreement on lowering drug prices in the US

Novartis and US government reach agreement on lowering drug prices in the US
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  • Novartis agrees to take actions aimed at meeting US Administration priorities for drug pricing
  • Additional Novartis medicines will be made available through direct-to-patient platforms in 2026
  • Company remains committed to investing in markets that value innovation and implement policies that support broad and fast access to medicines
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Novartis ianalumab significantly extends disease control in patients with immune thrombocytopenia with only four once-monthly doses

Novartis ianalumab significantly extends disease control in patients with immune thrombocytopenia with only four once-monthly doses
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  • Ianalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45% with patients maintaining disease control 2.8 times longer than with placebo plus eltrombopag1,2
  • 62% of patients treated with ianalumab plus eltrombopag achieved sustained platelet response at six months compared to 39% with placebo plus eltrombopag1,2
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1 in 4 metastatic breast cancer patients treated with Novartis Kisqali® remain progression-free beyond 4 years

1 in 4 metastatic breast cancer patients treated with Novartis Kisqali® remain progression-free beyond 4 years
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  • Progression-free response stayed consistent across age, BMI, and menopausal status in MONALEESA pooled analysis1
  • KISQALI is only CDK4/6i to demonstrate statistically significant overall survival (OS) in MBC across all Phase III trials2-12
  • New NATALEE 5-year sub-analysis data reinforce sustained reduction in distant disease-free survival in broadest population of EBC patients13
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Novartis data underscore pioneering scientific innovation in hematology and oncology at ASH and SABCS

Novartis data underscore pioneering scientific innovation in hematology and oncology at ASH and SABCS
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  • Positive results from ianalumab pivotal Phase III trial in ITP patients previously treated with corticosteroids to be presented as late-breaker
  • Scemblix data across clinical and real-world settings offer new evidence informing CML care amid evolving patient needs
  • 96-week pelabresib Phase III data represent longest follow-up of first-line myelofibrosis patients in randomized combination trial
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Novartis receives FDA approval for Itvisma®, the only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA)

Novartis receives FDA approval for Itvisma®, the only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA)
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Ad hoc announcement pursuant to Art. 53 LR

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Novartis projects +5-6% cc sales CAGR 2025-2030, with long-term growth backed by 30+ potential high-value pipeline assets

Novartis projects +5-6% cc sales CAGR 2025-2030, with long-term growth backed by 30+ potential high-value pipeline assets
arcticnovartis

Ad hoc announcement pursuant to Art. 53 LR

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