Key products in development
Novartis is consistently rated as having one of the industry’s most respected development pipelines, with more than 200 projects in clinical development, as of December 31, 2018. We highlight some promising late-stage projects, including new molecules and existing treatments that are under investigation for new indications.
BAF312 (siponimod, Mayzent1) is an investigational treatment for reducing disability progression in secondary progressive multiple sclerosis. It is a second-generation therapy based on a similar mechanism of action as Gilenya, an approved treatment for relapsing multiple sclerosis.
OMB157 (ofatumumab) is an antibody therapy under development for relapsing multiple sclerosis.
AVXS-101 (onasemnogene abeparvovec-xxxx, Zolgensma2) is an investigational gene replacement therapy for spinal muscular atrophy. This therapy targets the defective or missing gene that causes this fatal disease.
1 The brand name Mayzent has been provisionally approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAF312, but the product itself has not been approved for sale in any country.
2 The brand name Zolgensma has been provisionally approved by the FDA for AVXS-101, but the product itself has not received marketing authorization or Biologics License Application approval from any regulatory authorities.
Cosentyx is an antibody therapy under development for non-radiographic axial spondyloarthritis. Cosentyx is already an approved therapy for plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
KAF156 (ganaplacide) is an investigational treatment for malaria. This new class of molecules has the potential to clear malaria infections and block parasite transmission.
LJN452 (tropifexor) is an investigational treatment for the liver disease nonalcoholic steatohepatitis (NASH). LJN452 is designed to break the cycle of fat buildup that leads to inflammation and scarring of the liver.
Kymriah is a CAR-T therapy that genetically reprograms a patient’s immune cells to fight certain types of cancer. Kymriah is approved for B-cell acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL), and is under development for other blood cancers.
RTH258 (brolucizumab) is in late-stage development as an investigational antibody fragment therapy for neovascular age-related macular degeneration and diabetic macular edema. This treatment is designed to reduce the injection burden for patients.
UNR844 is an investigational treatment for presbyopia, the age-related loss of near-distance vision. UNR844 is potentially a first-in-class treatment to restore vision by softening the eye’s lens.
ACZ885 (canakinumab) is an antibody treatment under development for non-small cell lung cancer. ACZ885 is already an approved treatment, under the name Ilaris, for various inflammatory conditions, including cryopyrin-associated periodic syndrome and some forms of arthritis.
QAW039 (fevipiprant) is an investigational treatment for asthma. QAW039 is designed to improve lung function and reduce attacks in patients with moderate to severe asthma that is unresolved by other treatments.
BYL719 (alpelisib) is under development as a combination therapy to treat HR+/HER2- PIK3CA+ advanced breast cancer after progression on an endocrine-based regimen. This treatment is being tested in combination with fulvestrant to block cancer cell proliferation.
Kisqali is under development in multiple therapy combinations for a broad range of breast cancer patients, including men and premenopausal women. Kisqali is already an approved treatment for patients with advanced HR+/HER2- breast cancer.
Entresto is under development to treat chronic heart failure with preserved ejection fraction. Entresto is already an approved treatment for chronic heart failure with reduced ejection fraction.
Projects in clinical development
200+
Ongoing trials in Phase II or III for programs that have reached confirmatory development
Major approvals
20
Granted in 2018 by health authorities in the US, the EU and Japan for new treatments as well as new indications for existing treatments
Major submissions
20
Applications in 2018 to health authorities in the US, the EU and Japan for marketing approval for new treatments and new indications
For more information about the pipeline and progress on individual development programs www.novartis.com/our-science/novartis-global-pipeline