Novartis LNA043 for knee osteoarthritis gets USFDA fast track status
LNA043 is a ANGPTL3 agonist that targets damaged cartilage and modulates several pathways involved in cartilage regeneration.
New Delhi: Novartis has recently announced that the US Food and Drug Administration (USFDA) 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. 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 worldwide 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 alone.
A debilitating disease with increasing prevalence as societies age, 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 lesions. 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.
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