Otsuka announces NICE recommendation of Lupkynis® (voclosporin) with mycophenolate mofetil for treating active lupus nephritis

Otsuka announces NICE recommendation of Lupkynis^®      (voclosporin) with mycophenolate mofetil for treating active lupus nephritis

LONDON, UK, 3 May 2023 – Otsuka Pharmaceuticals (U.K.) Ltd. announces that the National Institute for Health and Care Excellence (NICE) has recommended 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 as a commercially arranged patient access scheme¹. 

The NICE recommendation applies to England and Wales¹ and stock is now available in both countries. This recommendation follows the recent Medicines and Healthcare Products Regulatory Agency (MHRA) authorisation of voclosporin as the first and only oral calcineurin inhibitor (CNI) licensed in Great Britain specifically for the treatment of active LN in adult patients. 

“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. 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 new combination treatment option could help to improve the lives of those living with lupus nephritis.”

The NICE appraisal is based on the positive results from the pivotal Phase 3 AURORA 1 study^2,3 and the AURORA 2 continuation study⁴, where the combination of voclosporin with MMF and corticosteroids was compared with MMF and corticosteroids alone.

“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,” said Ryan Gynne, Managing Director of Otsuka Pharmaceuticals (U.K.) Ltd.

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 damage⁵. UK data from 2012 showed that around 60,000 people were living with SLE, and around 3,000* people were diagnosed with SLE each year⁶. Around 40–60% of people with SLE develop LN^1,7,8.

*Data from 1999 to 2012.

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) LN⁹. 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 antigens⁹.

This medicine is subject to additional monitoring in relation to adverse reactions. This will allow quick identification of new safety information. You can help by reporting any side effects, see https://yellowcard.mhra.gov.uk/ for how to report these.

About AURORA clinical trials

The AURORA 1 study (completed in October 2019) was a Phase 3, prospective, double-blind, randomised trial comparing voclosporin plus MMF and corticosteroids (n=179) vs placebo plus MMF and corticosteroids (n=178) in patients with active LN class III or IV (alone or in combination with class V) or pure class V. The primary endpoint was to assess the efficacy of voclosporin compared with placebo in achieving renal response at 52 weeks of therapy; 73 (40.8%) and 40 (22.5%) patients in the voclosporin and placebo arms, respectively, achieved this (p<0.001)^2,9. Safety and adverse events were assessed through laboratory assessments, vital signs and physical examinations². The AURORA 2 study (completed in October 2021)⁴ was an extension to assess the long-term safety and efficacy of voclosporin (n=116) compared with placebo (n=100) for up to an additional 24 months in patients who completed treatment in the AURORA 1 study⁹.

About the collaboration between Otsuka Pharmaceutical Co., Ltd. and Aurinia

In December 2020, Otsuka Pharmaceutical Co., Ltd. entered into a collaboration and licensing agreement with Aurinia for the development and commercialisation of voclosporin for the treatment of LN in the European Union, Japan, the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

About voclosporin in other territories

The MHRA authorised voclosporin 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 Scottish Medicines Consortium (SMC) and the National Centre for Pharmacoeconomics Ireland (NCPE) reviews of voclosporin are currently pending.

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.