Otsuka’s lupus nephritis drug Lupkynis backed for NHS use

Patients in England and Wales with active lupus nephritis will soon be able to access treatment with Otsuka Pharma’s Lupkynis following a recommendation by the health technology assessment agency NICE.

Lupkynis (voclosporin) can be used in combination with the immunosuppressant drug mycophenolate mofetil (MMF) as an option for adults at the more severe end of the lupus nephritis spectrum, in other words, those with class 3, 4, and 5 disease, according to the guidance.

The drug was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in December, a few months after it was greenlit by the European Commission for the same indication in EU member states. It is the first oral calcineurin inhibitor (CNI) to be licensed for use in lupus nephritis.

Voclosporin costs £12,167 for 12 months of treatment, according to NICE, but Otsuka has agreed to supply the drug at a confidential discount to the NHS.

Originally developed by Canada’s Aurinia Pharma, Lupkynis is the first oral medicine to treat active lupus nephritis, which is a serious complication of the autoimmune disorder systemic lupus erythematosus (SLE) characterised by kidney inflammation.

Otsuka cites UK data from 2012 which suggests that around 60,000 people were living with SLE, with an estimated 3,000 new diagnoses every year. It is estimated that between 40% and 50% of all SLE patients will develop lupus nephritis, which is incurable and, depending on the severity, can require treatment over the course of their lifetime.

In the pivotal Phase 3 AURORA 1 study and AURORA 2 continuation study, where the combination of Lupkynis with MMF and low-dose corticosteroids was found to achieve superior renal responses at 52 weeks compared to MMF and steroids alone, with a comparable safety profile.

Otsuka licensed rights to Lupkynis in various ex-US markets, including the EU, Japan, and the UK, in 2020, with Aurinia retaining rights to the drug in the US and its home market of Canada. The Canadian firm recently said that it expects to make between $120 to $140 million in sales of the product in the current fiscal 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,” said Paul Howard, chief executive of patient organisation Lupus UK.

“From conversations with people living with lupus nephritis, we know that every day can be a challenge living with this disease,” he added. “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.”