Otsuka receives vital Lupkynis MHRA authorisation

Therapy represents first oral calcineurin-inhibitor treatment for active lupus nephritis in adults

Otsuka has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised Lupkynis for use in combination with mycophenolate mofetil.

The treatment – also known as voclosporin – involves adult patients with active class 3, 4 or 5 (including mixed class 3/5 and 4/5) lupus nephritis (LN). Furthermore, voclosporin is the first and only oral CNI licensed in Britain, specifically for the treatment of active LN in adult patients.

Voclosporin is a calcineurin-inhibitor immunosuppressant that inhibits calcineurin in a dose-dependent manner. The immunosuppressant activity results in the inhibition of lymphocyte proliferation, T-cell cytokine production and expression of T-cell activation surface antigens.

The MHRA authorisation is based on positive results from the pivotal phase 3 AURORA-1 study. It also uses comparative data from the AURORA-2 study, during which the combination of voclosporin with mycophenolate mofetil (MMF) and corticosteroids was compared to MMF and corticosteroids.

Ryan Gynne, managing director at Otsuka, reflected: “The MHRA’s authorisation of Lupkynis represents a significant development for lupus nephritis patients in Britain, offering voclosporin as a new combination treatment option for eligible patients.”

LN is a severe manifestation of systemic lupus erythematosus (SLE) – a chronic and debilitating autoimmune disease that can cause irreversible kidney damage. Indeed, UK data from 2012 showed that around 60,000 people were living with SLE, while around 3,000 people were being diagnosed with the condition every year. Approximately 40% to 60% of people with SLE ultimately develop lupus nephritis.

The MHRA decision regarding voclosporin applies to England, Scotland and Wales.

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