Lupkynis approved in Switzerland to treat adults with lupus nephritis
Approval specifically covers treatment of active class 3, 4, and 5 disease
Lupkynis (voclosporin) is now approved in Switzerland to treat adults with active lupus nephritis, a complication of lupus characterized by kidney damage and inflammation.
The approval specifically covers the treatment, given along immunosuppressants, for adults with active class 3, 4, and 5 lupus nephritis — three subtypes of the condition that are based on the type of tissue damage visible on a kidney biopsy.
Lupkynis is designed to block the activity of a protein called calcineurin, which is found in immune cells as well as kidney cells. By targeting this protein, the therapy aims to simultaneously dampen the inflammatory immune attack that drives lupus nephritis, while also helping to stabilize kidney cells.
Approval supported by data from Phase 3 AURORA trial and extension study
The Swiss Agency for Therapeutic Products (Swissmedic) has also granted Lupkynis an orphan drug designation, which gives its developer Aurinia Pharmaceuticals a guarantee of 15 years of market exclusivity for the medication associated with the approval.
“We are extremely pleased with the Swissmedic approval of Lupkynis for adults with lupus nephritis. This approval provides patients with an important treatment option and makes Lupkynis a more accessible therapy for patients experiencing [lupus nephritis],” Peter Greenleaf, Aurinia’s president and CEO, said in a company press release.
All of these approvals were supported by data from the Phase 3 AURORA trial (NCT03021499) and its extension study, AURORA 2 (NCT03597464). Findings suggested that Lupkynis helped preserve kidney function when given alongside mycophenolate mofetil and low-dose steroids (well-established anti-inflammatory therapies for lupus), without substantially increased safety risks.
The U.K.’s National Institute for Health and Care Excellence (NICE) recently recommended Lupkynis — when given alongside mycophenolate mofetil — for adults with active lupus nephritis classes 3, 4, or 5. These recommendations cover England and Wales.
“We are extremely pleased with the NICE recommendation of Lupkynis for patients with lupus nephritis,” Greenleaf said in a separate company press release. “This recommendation follows the earlier approval [in the U.K.] and further supports access to an important treatment option for those patients.”
Under a 2020 agreement, Lupkynis is being developed and marketed in Switzerland, the U.K., and other parts of Europe through a collaboration between Aurinia and Otsuka Pharmaceutical.
“Otsuka continues to be an important and valuable partner in our global efforts,” Greenleaf said.