Otsuka Pharmaceutical received the approval for Lupkynis (voclosporin) for use in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active class III, IV, or V (including mixed class III/V and IV/V) lupus nephritis (LN).
The decision was made by the European Commission, after Phase III trials showed that patients receiving the combination treatment, alongside low-dose corticosteroids, led to superior complete renal response rates at 52 weeks, when compared with MFF and corticosteroids alone.
LN is a severe form of systemic lupus erythematosus (SLE), which is a chronic autoimmune disease. The condition is experienced by approximately 210 people per 100,000 in Europe.
LN is easier to treat than SLE because the outcomes of the disease are easily understood, with it being possible to measure endpoints, such as the presence of certain proteins in urine. Voclosporin is an immunosuppressant that inhibits calcineurin, which is an enzyme that activates T cells known to play a role in autoimmune diseases, such as lupus.
A spokesperson for Otsuka told Outsourcing-Pharma that the treatment is expected to be launched in major European countries in the coming 12 months.
The spokesperson also confirmed that the manufacturing and supply of the medication will be managed by its partner, Aurinia Pharmaceuticals. They added that there are ‘a number of steps’ in the supply chain network, but that it is effectively managed to ensure the treatment is accessible to patients.
In 2020, the two companies entered an agreement that saw Aurinia receive $50m (€50m) in upfront payments, plus an additional $50m in regulatory and reimbursement milestone payments in exchange for Otsuka gaining the development and commercialization rights.
The collaboration agreement also saw Otsuka agree to pay royalties up to 20% on net sales from the commercialization process in Europe and Japan.
Previously, Lonza had been contracted to produce the active pharmaceutical ingredient (API) and the company held the option to be the exclusive supplier of the API should Aurinia gain approval for the treatment. The US Food and Drug Administration (FDA) approved the treatment for the same indication in 2021.
Voclosporin has changed hands a number of times between different companies, before finally being brought to approval for lupus by Aurinia and Otsuka.
The treatment was originally discovered by Isotechnika Pharma, a Canadian pharma company, which then licensed the drug candidate to Roche in 2002. After trying and failing to develop the drug for the prevention of organ rejection after transplant, the pharma giant handed back the rights.
Lux Biosciences also tried to progress the treatment as a therapy for an eye disorder, known as uveitis, but without success. Eventually, Isotechnika merged with Aurinia in 2013, as an effort to take voclosporin through to approval.