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

Fast-track status aids in developing and accelerating the review of therapies for the treatment of serious ailments and to meet unmet medical needs.

Being developed as a potential disease-alerting modifying therapy for osteoarthritis, LNA043 is an angiopoietin-like 3 (ANGPTL3) agonist.

It acts on injured cartilage and regulates various pathways associated with cartilage regeneration.

Identified within the Novartis Institutes for BioMedical Research, LNA043 is among several early experimental programmes in the company’s portfolio that work on cartilage damage and inflammation in OA.

The treatment with intra-articular injections of LNA043 offered regeneration of injured cartilage in patients with femoral articular cartilage lesions, in a proof-of-concept (PoC) clinical trial.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Currently, a Phase IIb trial of the drug is progressing in patients with knee OA.

The Phase IIb study is a segment of the two-part, randomised, placebo-controlled Phase II trial studying LNA043’s safety, tolerability and preliminary efficacy in approximately 133 patients.

Started in September 2017, the Phase II trial is expected to complete in September next year.

A chronic degenerative condition, OA causes a gradual loss of cartilage, causing pain, joint function loss and disability.

It affects more than 300 million individuals globally posing a substantial and rising burden to healthcare systems, often occurring in the knees with more than one million knee replacements anticipated to happen in the US in a year.

Current pharmacologic therapies only target symptoms such as pain, Novartis noted.

This indicates a significant and growing requirement for a disease-modifying treatment to sustain or regenerate cartilage and alter the disease’s natural course.

In June, the FDA granted breakthrough therapy designation to Novartis’ ¹⁷⁷Lu-PSMA-617 to treat metastatic castration-resistant prostate cancer.

An investigational radioligand therapy, ¹⁷⁷Lu-PSMA-617 is a combination of a targeting compound and a therapeutic radioisotope.