Otsuka announces Scottish Medicines Consortium acceptance of Lupkynis®(voclosporin) with mycophenolate mofetil for treating active lupus nephritis
LONDON, UK, 9 October 2023 – Otsuka Pharmaceuticals (U.K.) Ltd. today announces that the Scottish Medicines Consortium (SMC) has accepted Lupkynis® (voclosporin) in combination with mycophenolate mofetil (MMF) as an option for treating adults with active lupus nephritis (LN) class III, IV or V (including mixed class III/V and IV/V), when provided via a patient access scheme1.
“We are very pleased that the Scottish Medicines Consortium has recommended voclosporin for use in NHS Scotland, following NICE’s recommendation adopted by England and Wales earlier this year. 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. From conversations with people living with lupus nephritis, we know that every day can be a challenge living with this disease,” said Paul Howard, Chief Executive of LUPUS UK. “We hope that the introduction of voclosporin as a combination treatment option could help to improve the lives of those living with lupus nephritis.”
“The SMC acceptance of Lupkynis is an important milestone for Scottish patients living with lupus nephritis, this underpins the aim of Otsuka to be an indispensable contributor to people's health worldwide,” said Ryan Gynne, Managing Director of Otsuka Pharmaceuticals (U.K.) Ltd.
NICE (National Institute for Health and Care Excellence) recommended the use of voclosporin on the NHS earlier this year, following the MHRA (Medicines and Healthcare Products Regulatory Agency) authorising the treatment in 2022 for use in combination with MMF for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) LN. The MHRA decision applies to England, Scotland and Wales. Voclosporin is also authorised for use in Northern Ireland (by the European Commission). The National Centre for Pharmacoeconomics Ireland (NCPE) reviews of voclosporin are currently pending.
About lupus nephritis (LN)
LN is a severe manifestation of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease that can cause irreversible kidney damage2. UK data from 2012 showed that around 60,000 people were living with SLE, and around 3,000* people were diagnosed with SLE each year3. Around 40–60% of people with SLE develop LN4,5.
About voclosporin
Voclosporin is indicated in combination with MMF for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) LN6. Voclosporin is a calcineurin inhibitor immunosuppressant that inhibits calcineurin in a dose-dependent manner up to a maximum dose of 1.0 mg/kg. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production and expression of T-cell activation surface antigens6.
About Otsuka
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide. Otsuka researches, develops, manufactures and markets innovative products, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs in several under-addressed diseases including tuberculosis, a significant global public health issue.
Otsuka Europe employs over 500 people and focuses on psychiatric and neurologic disorders, infectious disease, nephrology, oncology, and digital medicines. Otsuka Pharmaceutical Europe Ltd. is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.
The Otsuka group of companies employed 47,000 people worldwide with consolidated sales of approximately €12.4 billion and a spend of €1.7 billion on research and development in 2022.
