Novartis data show rapid and effective disease activity control with remibrutinib (LOU064) in patients with chronic spontaneous urticaria
  • Results from a Phase IIb study show all remibrutinib doses provided significant improvements in UAS7 change from baseline at week 4 and week 12 compared to placebo, and a favorable safety profile across the entire dose range tested
  • All doses provided clinically meaningful improvements with respect to the proportion of patients achieving UAS7=0 (complete absence of hives and itch) and UAS7≤6 (well-controlled disease activity) vs. placebo over the treatment period, starting as early as Week 1

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Novartis accelerates efforts toward ESG targets to increase access to medicines, improve health equity and achieve net-zero carbon emissions
  • Reached nearly 29 million patients to date in 2021 through our flagship programs and strategic innovative brands

  • Announced a planned 10-year commitment with historically black colleges and universities to address root causes of systemic disparities in health outcomes

  • Continued our global health leadership with positive phase 2b results for our next generation antimalarial therapy ganaplacide in combination with lumefantrine which support its continued development

  • Committed to achieving net zero …
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Novartis and Medicines for Malaria Venture report positive results for Phase 2b study of novel ganaplacide/lumefantrine combination in children with malaria
  • Novartis and Medicines for Malaria Venture (MMV) report positive Phase 2b study results for novel non-artemisinin combination to treat uncomplicated malaria
  • In the Phase 2b study conducted in children less than 12 years of age, ganaplacide/lumefantrine met the primary study objective
  • The positive Phase 2b results for the next generation antimalarial therapy support continued development of the combination

Basel, September 29 …

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New data reinforce efficacy and convenience of Novartis Cosentyx® (secukinumab) 300 mg autoinjector in adults with psoriasis
  • New findings show Cosentyx® (secukinumab) 300 mg single dose autoinjector (the UnoReady® pen) resulted in superior efficacy vs placebo1
  • Patient satisfaction with 300 mg autoinjector was high – reaching 100% – with no new safety signals observed over 52 weeks1
  • Cosentyx is a proven medicine supported by sustained efficacy and safety data across several systemic inflammatory conditions2-6, with more than 500 …
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Novartis data show achieving complete control of chronic spontaneous urticaria (CSU) improves overall quality of life, as reported by patients
  • Data analysis shows that preventing the symptoms of CSU (achieving complete control) improves overall health-related quality of life (HRQoL); including sleep and work productivity, among other measures1
  • Complete control of CSU symptoms, assessed by a composite of patient reported outcomes (PROs), is more likely to be achieved and sustained with ligelizumab than Xolair® (omalizumab) or placebo2
  • Phase III results are expected in H2 2021 with first regulatory …
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FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC)

Novartis announced today that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting. With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide …

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FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC)

Novartis announced today that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting. With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide …

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Novartis acquires Arctos Medical, expanding optogenetics portfolio to bring gene therapies to patients with severe vision loss
  • Acquisition underscores Novartis commitment to using optogenetics-based therapies to restore vision to patients with advanced blindness
  • Novartis gains one pre-clinical optogenetic AAV gene therapy program and Arctos’ proprietary technology introducing a distinct mechanism of action
  • Technology joins growing portfolio being developed at Novartis for potential treatment of vision loss

Basel, September 21, 2021 — Novartis today announced that it has acquired Arctos Medical, adding a pre- …

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Novartis announces collaboration on HARMONIA, a Phase III, head-to-head trial evaluating Kisqali® vs. Ibrance®* in patients with HR+/HER2- advanced breast cancer

  • HARMONIA seeks to identify the best therapeutic option between Kisqali and Ibrance® for patients with aggressive HER2-enriched intrinsic subtype of HR+/HER2- advanced breast cancer (ABC)
  • HARMONIA is intended to test whether Kisqali changes tumor biology to enable a better response to endocrine-based therapy even within the more aggressive subtypes, improving the course of HR+/HER2- disease
  • Kisqali is unique as the only CDK4/6 inhibitor with proven overall survival benefit in all three pivotal trials, with …
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Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer

  • With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting2
  • Kisqali plus letrozole achieved median OS of over five years (63.9 months), a survival benefit of over 12 months vs. placebo plus letrozole in postmenopausal women (HR=0.76; p=0.004)2
  • Kisqali is the only CDK4/6 inhibitor with proven OS benefit across all …
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