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MHRA authorises Otsuka’s combination treatment for lupus nephritis

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised Otsuka’s 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).

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 antigens4.

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 authorisation is based on the positive results from the pivotal Phase 3 AURORA-1 study1,2 and the AURORA-2 continuation study3, where the combination of voclosporin with mycophenolate mofetil (MMF) and corticosteroids was compared to MMF and corticosteroids alone.

Ryan Gynne, Managing Director of Otsuka Pharmaceuticals UK Ltd said: “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.”

References

1 Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021 May 29;397(10289):2070-2080

2 ClinicalTrials.gov. Aurinia Renal Response in Active Lupus With Voclosporin (AURORA). NCT03021499. Available from: https://clinicaltrials.gov/ct2/show/NCT03021499 [Last accessed: November 2022].

3 ClinicalTrials.gov. Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2), NCT03597464. Available from: https://clinicaltrials.gov/ct2/show/NCT03597464 [Last accessed: November 2022].

4 Lupkynis EU Summary of product characteristics (SmPC) [last accessed: November 2022].

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Emma Cooper
Emma Cooper
Emma is Content Manager at Pf Media.

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