MHRA Approves LUPKYNIS to Treat Active Lupus Nephritis in Adults

Strategic Insights -

LUPKYNIS, the first oral medicine approved in the US and Europe for the treatment of adults with active lupus nephritis, has received marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This approval follows the European Commission's authorization on September 19, 2022, and expands the availability of LUPKYNIS as a treatment option for people with lupus nephritis.

Key Takeaways:

  • The MHRA approval of LUPKYNIS for the treatment of adults with active lupus nephritis in Great Britain is based on the Phase 3 AURORA 1 study and the AURORA 2 continuation study.
  • The studies demonstrated that voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids alone.
  • The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.
  • LUPKYNIS is the first U.S. FDA- and EC-approved oral medicine for the treatment of adult patients with active lupus nephritis.
  • The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring.
  • Dose modifications can be made based on Aurinia's proprietary personalized eGFR-based dosing protocol.
  • LUPKYNIS carries a boxed warning for increased risk of malignancies and serious infections.
  • Other warnings and precautions include lymphoma and other malignancies, serious infections, nephrotoxicity, hypertension, neurotoxicity, hyperkalemia, and QTc prolongation.
  • Live attenuated vaccines should be avoided during treatment with LUPKYNIS.
  • Cases of pure red cell aplasia have been reported in patients treated with another CNI immunosuppressant.
  • Co-administration with strong CYP3A4 inhibitors or strong or moderate CYP3A4 inducers should be avoided.
  • Dosage reduction may be necessary when co-administered with moderate CYP3A4 inhibitors.
  • Certain P-gp substrates with narrow therapeutic windows may require dosage reduction when co-administered.

Statistics:

  • About 200,000-300,000 people live with systemic lupus erythematosus (SLE) in the US, with one-third of these individuals diagnosed with lupus nephritis.
  • Black and Asian individuals with SLE are four times more likely to develop lupus nephritis, and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared to Caucasian individuals.
  • Black and Hispanic individuals with SLE tend to develop lupus nephritis earlier and have poorer outcomes when compared to Caucasian individuals.
  • LUPKYNIS has a recommended starting dose of three capsules twice daily, with no requirement for serum drug monitoring.
  • Dose modifications can be made based on Aurinia's proprietary personalized eGFR-based dosing protocol.

Sources:

  • Aurinia Pharmaceuticals press release, "Aurinia Announces MHRA Approval of LUPKYNIS (voclosporin) for the Treatment of Adults with Active Lupus Nephritis in Great Britain", November 30, 2022
  • European Commission approval of LUPKYNIS for the treatment of adults with active lupus nephritis, September 19, 2022
  • Aurinia Pharmaceuticals, "LUPKYNIS (voclosporin) Prescribing Information", November 2022
  • Businesswire, "Aurinia Announces MHRA Approval of LUPKYNIS (voclosporin) for the Treatment of Adults with Active Lupus Nephritis in Great Britain", November 30, 2022