Novartis receives FDA fast track designation for LNA043 in osteoarthritis of the knee

Sep 02, 2021

Novartis today announced that the US Food and Drug Administration (FDA) has granted fast track designation for LNA043 for the treatment for osteoarthritis of the knee. Fast track designation facilitates the development and expedites the review of drugs to treat serious conditions and fill unmet medical needs.1 LNA043 is being developed as a potential first in class disease modifying treatment for osteoarthritis (OA). 

OA is a chronic degenerative disease characterized by a progressive loss of cartilage, leading to pain, loss of joint function and disability. It affects over 300 million people worldwide2 posing a significant and growing burden to healthcare systems, often presenting in the knees with over 1 million knee replacements estimated to take place annually in the US alone3.  

A debilitating disease with increasing prevalence as societies age4, existing pharmacologic treatments only address symptoms such as pain, meaning there is a significant and growing need for a disease modifying therapy that could maintain or regenerate cartilage and change the natural course of the disease.

LNA043 is a ANGPTL3 agonist that targets damaged cartilage and modulates several pathways involved in cartilage regeneration. In a proof of concept study, treatment with intra-articular injections of LNA043 resulted in regeneration of damaged cartilage in patients with femoral articular cartilage lesions5. A Phase IIb study in patients with knee OA is underway.

Discovered within the Novartis Institutes for BioMedical Research, LNA043 is among a number of early investigational programs in Novartis’s portfolio that target cartilage damage and inflammation in OA. 

  1. U.S. Food and Drug Administration (FDA). Fast Track. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
  2. The National Center for Biotechnology Information (NCBI), A systematic analysis for the Global Burden of disease study 2017. Available from: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6227754/].
  3. Singh, J, A,,et al. (2019). Rates of Total Joint Replacement in the United States: Future projections to 2020-2040 Using the National Inpatient Sample. Journal of Rheumatology.
  4. Osteoarthritis Research Society International (OARSI) (2016) Osteoarthritis: A Serious Disease. Submitted to the US Food and Drug Administration.
  5. Trattnig, S., et al. Anabolic effect of LNA043, a novel disease-modifying osteoarthritis drug candidate: results from an imaging-based proof-of-concept trial in patients with focal articular cartilage lesions. Annals of the Rheumatic Diseases 2021;80:363.

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