Otsuka’s Lupkynis receives NICE green light

Recommendation applies across England and Wales and the treatment is available now

Otsuka Pharmaceuticals has revealed that the National Institute for Health and Care Excellence (NICE) has recommended Lupkynis in combination with mycophenolate mofetil (MMF).

The treatment has been developed as a therapy for adults with active lupus nephritis (LN) class 3, 4 or 5 – including mixed class 3/5 and 4/5 – when provided as a commercially arranged patient access scheme.

The NICE recommendation applies across England and Wales and the treatment is currently available throughout both countries. The decision follows the Medicines and Healthcare Products Regulatory Agency (MHRA) authorisation of Lupkynis – also known as voclosporin – as the first and only oral calcineurin inhibitor (CNI) licensed in Great Britain for the treatment of active LN among adult patients.

The appraisal has merged after positive results from the pivotal phase 3 AURORA studies, where the combination of voclosporin with MMF and corticosteroids was widely contrasted with MMF and corticosteroids alone.

Ryan Gynne, managing director of Otsuka, was in no doubt that the decision will change lives for the better: “The NICE recommendation of Lupkynis is an important milestone for those living with this serious condition, reinforcing the commitment of Otsuka to bringing innovative solutions to patients for better health worldwide.”

Paul Howard, chief executive at LUPUS UK, reflected: “We are delighted that NICE has recommended voclosporin for use in the NHS. The combination of symptoms such as joint pain, swelling and fatigue caused by lupus nephritis can be very detrimental to mental wellbeing and quality of life.”

He concluded: “From conversations with people living with lupus nephritis, we know that every day can be a challenge living with this disease. We hope that the introduction of voclosporin as a new combination treatment option could help to improve the lives of those living with lupus nephritis.”

LN is a chronic and life-limiting autoimmune disease that can cause irreversible kidney damage. Data from the UK in 2012 demonstrated that around 60,000 people were living with SLE and around 3,000 people were diagnosed with SLE every year.