FDA grants fast track designation for Novartis’ LNA043 to treat osteoarthritis

The US Food and Drug Administration (FDA) has granted fast track designation for Novartis’ agonist LNA043 to treat knee osteoarthritis.

LNA043, which has been discovered within the Novartis Institutes for BioMedical Research, is being developed as a potential first in class disease modifying treatment for osteoarthritis (OA).

The chronic degenerative disease OA is characterised by a progressive loss of cartilage, which leads to pain, loss of joint function and disability.

This disease affects more than 300 million people across the globe and poses a significant burden to healthcare systems.

Fast track designation from the FDA facilitates the drug development and expedites its review for the treatment of serious conditions and fill unmet medical needs.

The ANGPTL3 agonist LNA043 targets damaged cartilage and modulates several pathways that are involved in cartilage regeneration.

Treatment with intra-articular injections of LNA043 resulted in regeneration of damaged cartilage in patients with femoral articular cartilage lesions, in a proof of concept study.

At present, a Phase IIb study in patients with knee OA is underway.

Novartis noted that LNA043 is among several early investigational programmes in its portfolio that target cartilage damage and inflammation in OA.

In a separate development, Novartis has signed a commercial agreement with the NHS in England which enables broad and rapid access to first-in-class cholesterol-lowering medicine Leqvio.

The agreement follows the positive final recommendation from the National Institute for Health and Care Excellence (NICE) and commits to deliver Leqvio (inclisiran) access through a population health management approach identifying eligible patients across England.

Novartis CEO Vas Narasimhan said: “This pioneering collaboration with the NHS in England has the potential to spur a step-change improvement in cardiovascular health across the UK, and it demonstrates Novartis’ commitment to working with healthcare systems around the world to improve patient outcomes by co-creating novel access solutions for innovative medicines.”