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Otsuka announces MHRA authorisation of Lupkynis® (voclosporin) as first oral calcineurin-inhibitor ▼ (CNI) for active lupus nephritis

LONDON, UK, 30 November 2022 – Otsuka Pharmaceuticals UK Ltd. announces that the MHRA (Medicines and Healthcare Products Regulatory Agency) has authorised Lupkynis® (voclosporin) for use in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN). The MHRA decision applies to England, Scotland, and Wales (Great Britain). Voclosporin is the first and only oral CNI licensed in Great Britain (GB) specifically for the treatment of active LN in adult patients. 

“The MHRA’s authorisation of Lupkynis represents a significant development for lupus nephritis patients in Great Britain, offering voclosporin as a new combination treatment option for eligible patients.” said Ryan Gynne, Managing Director of Otsuka Pharmaceuticals UK Ltd. 

LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease, that can cause irreversible kidney damage4. UK data from 2012 showed that around 60,000 people were living with SLE and around 3,000* people were diagnosed with SLE each year5. Around 40% to 60% of people with SLE develop lupus nephritis6,7.

About voclosporin

Voclosporin is a calcineurin-inhibitor immunosuppressant that inhibits calcineurin in a dose-dependent manner up to a maximum dose of 1.0mg/kg. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens8.

▼ This medicine is subject to additional monitoring in relati…

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Otsuka announces MHRA authorisation of Lupkynis®    (voclosporin) as first oral calcineurin-inhibitor ▼ (CNI) for active lupus nephritis

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