Aurinia OK’d to Apply for New Lupkynis Patent for Lupus Nephritis

Application covers method to use medicine with immunosuppressives, anti-inflammatories

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Patent and Trademark Office (USPTO) has allowed Aurinia Pharmaceuticals submit a new patented method of using Lupkynis (voclosporin), its approved oral treatment for lupus nephritis.

The new application (No. 17/713,140), titled, “Improved Protocol for Treatment of Lupus Nephritis,” covers a method of using Lupkynis in combination with two other common types of immunosuppressive and anti-inflammatory therapies that are part of standard of care treatment for lupus, mycophenolate mofetil (MMF; sold under the brand name CellCept) and corticosteroids.

The method uses the estimated glomerular filtration rate (eGFR), a measure of kidney function, to guide dosing. This method is consistent with that on the therapy’s label that was previously approved by the U.S. Food and Drug Administration (FDA).

If the patent is approved, it would add intellectual property protections to Aurinia’s existing patent on Lupkynis (U.S. Patent No. 10,286,036) that could provide patent protection up to 2037.

Aurinia also announced the European Patent Office (EPO) intends to grant a patent similar to the company’s current one for Lupkynis in the U.S. If issued, this patent could provide protection for Lupkynis across Europe up to 2037.

“This allowance by the USPTO and the concomitant news from the European Patent Office further strengthens our Intellectual Property portfolio as it pertains to Lupkynis and its unique pharmacodynamic dosing protocol which is detailed in the FDA package insert,” said Peter Greenleaf, CEO of Aurinia, in a press release. “These new patents, once issued, will enhance the long-term potential of Lupkynis.”

Lupus nephritis is a serious complication of lupus. It occurs when the immune system mistakenly attacks and damages the kidneys, which are responsible for filtering out waste products from the bloodstream.

Lupkynis, which targets the protein calcineurin, is designed to simultaneously reduce the inflammatory activity of immune cells that drive lupus and promote the stability of cells in the kidneys.

The FDA approved Lupkynis for lupus nephritis in 2021. The therapy was approved for the same indication in Europe and the U.K. last year.

Approvals were supported by data from the Phase 3 AURORA trial (NCT03021499), which showed that people with lupus nephritis given Lupkynis in addition to standard of care were more likely to have stable kidney function than with a placebo.