Sep 20 Lupus Nephritis

Roche’s Gazyva receives FDA Breakthrough designation for Lupus nephritis

The US FDA has in a recent move granted Roche’s Gazyva Breakthrough Therapy Designation (BTD) for adults with lupus nephritis.

Gazyva (obinutuzumab) is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Classified as a "monoclonal antibody", Gazyva is a CD20-directed cytolytic antibody. The drug is recommended in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). Furthermore, Gazyva is also indicated in combination with bendamustine for the treatment of of follicular lymphoma (FL) with a prior rituximab-containing therapy regimen.

The decision for granting a Breakthrough designation to Gazyva came on the basis of results of the phase II NOBILITY trial in adult patients with proliferative lupus nephritis.

The administration of Gazyva in combination with mycophenolate mofetil or mycophenolic acid and corticosteroids validated its efficacy in patients with lupus nephritis.

Lupus nephritis

Lupus nephritis is an autoimmune kidney disease caused by systemic lupus erythematosus.

Symptoms of lupus nephritis include foamy urine and edema.
The person may also develop high blood pressure.

Lupus nephritis Epidemiology

Lupus nephritis is clinically evident in 50-60% of patients with systemic lupus erythematosus (SLE), and it is histologically evident in most SLE patients, even those without clinical manifestations of renal disease.

Kidney damage is one of the common health problems associated with lupus. In adults, as many as 5 out of 10 lupus patients will have kidney disease. In children, the number is 8 out of 10.

Lupus nephritis Therapeutic landscape

The treatment of LN consists of two phases - induction and maintenance. Induction therapy refers to the initial therapeutic regimen given in an attempt to produce remission of active disease.

The combination of cyclophosphamide and corticosteroids (methylprednisolone) administered as induction therapy has proved to be effective in randomized controlled trials. Moreover, the studies revealed that the combination is more effective than corticosteroids alone.

Mycophenolate mofetil (MMF) was introduced as a therapeutic option for LN in the beginning of the 21st century.

Various therapies have been studied for maintenance therapy, including azathioprine, MMF, and cyclophosphamide, all combined with corticosteroids.

Lupus nephritis Upcoming therapies

Many other agents are currently under investigations to study how they impact Lupus nephritis treatment including rituximab, belimumab, and tacrolimus.

The Lupus Nephritis market is expected to experience positive growth in the coming years owing to the launch of distinctive emerging therapies in the coming years.

Companies like Aurinia Pharmaceuticals (Voclosporin), Roche (Obinutuzumab), AstraZeneca (Anifrolumab), Novartis (CFZ533), Boehringer Ingelheim (BI 655064) and many other pharma companies are working towards the expansion of Lupus Nephritis treatment therapies.

Voclosporin, an investigational drug, is a novel and potentially best-in-class CNI with clinical data in over 2,400 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action.

Apart from the late-stage therapies, there are other Lupus nephritis promising candidates as well, which are still in the early stage of development.

Kezar Lifesciences’ KZR-616 is one of the early-stage molecules, which is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across autoimmune diseases. The drug is currently being tested under Phase-1/2 clinical trial.

Lupus nephritis Market trends

The dynamics of Lupus Nephritis market is anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, rising awareness of the disease, incremental healthcare spending across the world and expected launch of emerging therapies during the forecast period of 2018-2028.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.