BRIEF—British approval for Lupkynis in lupus nephritis

Japanese drugmaker Otsuka Pharmaceuticals has announced the British authorization of Lupkynis (voclosporin) for use in combination with mycophenolate mofetil for the treatment of adults with active class III, IV or V lupus nephritis (LN).

The Medicines and Healthcare Regulatory Agency decision applies to England, Scotland, and Wales. Lupkynis is the first and only oral CNI licensed in Great Britain specifically for the treatment of active LN in adult patients.

This authorization is based on the positive results from the pivotal Phase III AURORA-1 study and the AURORA-2 continuation trial, where the combination of voclosporin with mycophenolate mofetil (MMF) and corticosteroids was compared to MMF and corticosteroids alone.

LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease, that can cause irreversible kidney damage.

UK data from 2012 showed that around 60,000 people were living with SLE and around 3,000 were diagnosed with SLE each year. Around 40% to 60% of people with SLE develop LN.

In December 2020, Otsuka entered into a collaboration and licensing agreement with Aurinia Pharmaceuticals for the development and commercialization of voclosporin for the treatment of LN in the European Union, Japan, the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.