Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

Basel, June 2, 2020 —  Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020.

“Novartis will continue to work with the FDA to complete the review as soon as possible,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “We are well prepared …

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European Patient Innovation Summit publishes call for action to ensure greater patient involvement in digital health solution development

A new ‘Call to Action’ has been published by the European Patient Innovation Summit (EPIS) Steering Committee, calling for multiple stakeholders to ensure patients have a voice in the future of digital health solution development.

It will take the united efforts of all stakeholders to ensure the patient voice is stronger in digital health solution development,

Patrick Little, European Migraine & Headache Alliance (EMHA), Ireland

The new call to action challenges all parties involved in the …

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Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery

  • More than half of patients with BRAF-mutated advanced melanoma taking Tafinlar + Mekinist were alive and free of a relapse at 5-years1
     
  • Study conclusions are drawn from the largest dataset and longest follow-up to date of patients with BRAF-mutated melanoma treated with targeted therapy following the surgical removal of their cancer1,2
     
  • Data are from the five-year follow-up of the COMBI-AD trial presented at the ASCO20 Virtual Scientific Program1

Basel, May 29, 2020 …

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Novartis Piqray® receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation

  • Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast cancer patients whose tumors harbor a PIK3CA mutation in Europe
     
  • Phase III trial showed Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. 5.7 months) in this patient population, compared to fulvestrant alone
     
  • PIK3CA mutations affect approximately 40% of HR+/HER2- advanced breast cancer patients and are linked to cancer growth and a poorer disease prognosis in the metastatic setting

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Novartis data highlight benefit of early treatment initiation in patients with secondary progressive multiple sclerosis (SPMS)

  • Novartis presented a total of 34 abstracts at the Congress of the European Academy of Neurology (EAN), emphasizing its strong multiple sclerosis (MS) portfolio with 20 abstracts
  • Long-term efficacy data from EXPAND, previously presented at the American Association of Neurology Congress, show patients with SPMS continuously treated with Mayzent® (siponimod) experienced a sustained effect in delaying disability for up to 5 years, demonstrating the advantages of early treatment1
     
  • These …
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Novartis update following WHO Solidarity trial announcement

On May 25, 2020 the World Health Organization (WHO) announced a temporary pause of the hydroxychloroquine (HCQ) arm within the Solidarity trial. The decision was based, in part, on publication in The Lancet 1 of an analysis of hydroxycholoroquine and chloroquine and their effects on hospitalized COVID-19 patients. Novartis has taken note of this retrospective, observational study of existing multinational hospital registry data and our medical teams are evaluating the findings reported in the publication.

The medical evidence on hydroxychloroquine in COVID-19 …

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Novartis at ASCO

We are boldly reimagining cancer and blood disorders.

Novartis ASCO20 Virtual Portal

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Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease

  • New MONALEESA-7 (M7) and MONALEESA-3 (M3) subgroup analysis to be presented during ASCO20 Virtual Scientific Program
     
  • Subgroup analysis shows Kisqali plus endocrine therapy extended life compared to endocrine therapy for patients with liver metastases – showing ~47% and 37% reduction in the risk of death in M7 and M3, respectively1
     
  • Visceral metastases, especially liver or brain metastases, generally signify a poor prognosis and more aggressive disease for patients2,3 …
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Novartis announces new late-breaking ofatumumab data at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS)

  • Rapid and profound depletion of B-cells contributed to a halt in disease activity in RMS patients1
     
  • A post hoc analysis showed 47.0% and 87.8% of patients treated with ofatumumab achieved no evidence of disease activity (NEDA-3) within the first (0–12 months) and second year (12–24 months) of treatment, respectively1
     
  • Regulatory action for ofatumumab in RMS in the US is expected in June 2020
     
  • If approved, ofatumumab has the potential to become a first-choice treatment for RMS …
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Novartis study reveals that migraine support in the workspace can significantly decrease the impact of the disease on affected employees

  • The patients that completed the Migraine Care pilot program reported over 50% reduction in migraine disability and a significant improvement in their patient activation measure after six months
     
  • Participants received six monthly sessions of individualized telecoaching comprised of educational modules and action plans from a specialized nurse by phone and through a specially developed module on the Migraine Buddy smartphone application
     
  • The program was provided as a complimentary service to all Swiss-based …
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