Novartis receives EC approval for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps

  • EC approves Xolair® (omalizumab) as an add-on therapy for severe chronic rhinosinusitis with nasal polyps, the first anti-immunoglobulin E antibody approved in this indication1
  • Chronic rhinosinusitis with nasal polyps is a debilitating condition for many patients, with symptoms including nasal blockage, difficulty breathing and sleeping, and loss of sense of smell, which reduce quality of life2–4
     
  • Approval builds on well-established efficacy and safety record of Xolair, which has over 1.3 million …
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Ensuring medicine supply to patients during COVID-19

Kalwe, India: staying on site to ensure leprosy drug production

Multidrug therapy (MDT) was a major breakthrough in the fight against leprosy and remains the cornerstone of the global leprosy elimination strategy. The Sandoz Kalwe site, located north of Mumbai on India’s west coast, manufactures and supplies MDT to the World Health Organization as part of the Novartis pledge to donate MDT medicines to eliminate leprosy. But in March, manufacturing and supplying MDT became a …

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Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

  • Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis1
     
  • ASCLEPIOS I and II demonstrated significant reductions in risk of relapses, confirmed disability worsening and profound reduction of active or new brain lesions1
     
  • The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple …
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Novartis announces Kymriah® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma

  • Global ELARA trial demonstrated clinically meaningful benefit in patients with relapsed or refractory (r/r) follicular lymphoma (FL) as measured by complete response rate
     
  • Kymriah previously received FDA Regenerative Medicine Advanced Therapy (RMAT) designation in r/r FL based on preliminary ELARA trial findings, reflecting the unmet need for additional treatment options for this cancer type
     
  • ELARA trial findings will be included in regulatory submissions, with filing in the US anticipated in 2021, and the EU following. Results will be …
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Novartis Cosentyx® receives EU approval for first-line systemic treatment in pediatric psoriasis

  • EU approval is based on two Phase III studies showing Cosentyx® provides fast and strong skin clearance, along with significant improvement in quality of life and a favorable safety profile1
     
  • Moderate-to-severe psoriasis affects more than 350,000 children worldwide2, with the physical and psychological burden disrupting important formative years3
     
  • Cosentyx is a proven brand, supported by long-term five-year sustained efficacy and safety data across psoriasis, psoriatic arthritis ( …
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