Approvals

Otsuka Pharmaceuticals has announced that the National Institute for Health and Care Excellence (NICE) has recommended Lupkynis (voclosporin) in combination with mycophenolate mofetil (MMF) as a treatment option for adult patients with active lupus nephritis (LN).

NICE’s recommendation applies to England and Wales with stock already available in both of these countries. The recommendation follows the Medicines and Healthcare Products Regulatory Agency’s (MHRA) recent authorisation of voclosporin as the first and only oral calcineurin inhibitor (CNI) to be licensed in Great Britain specifically to treat active LN in adult patients.

The recommendation also follows positive results from the pivotal phase 3 AURORA 1 study and the AURORA 2 continuation study, which assessed the combination of voclosporin with MMF and corticosteroids compared to MMF and corticosteroids alone.

Paul Howard, chief executive of LUPUS UK, commented: “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 well-being 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.

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.”

Ryan Gynne, managing director of Otsuka Pharmaceuticals, added: “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.”