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FDA Approves New Tx for Lupus – Lupkynis

Lupus Tx

The FDA has approved a new, first ever therapy for Lupus nephritis, Lupkynis (voclosporin) from Aurinia Pharmaceuticals, in combination with background immunosuppressive therapy. It is indicated for the treatment of adult patients with active lupus nephritis (LN) . Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex, and autoimmune disease.

Lupkynis has been approved with a black box warning including malignancies and serious infections.

About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals, +-85,000, have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure.

In the past, repurposed anti-inflammation drugs, steroids, immunosuppressants and antimalarials like hydroxychloroquine were the only options to manage lupus symptoms. The last approval for LN was ten years ago in 2011, Benlysta.

Aurinia announced in an investor call that it has targeted ~12,000 physicians in the rollout and has already approached ~50 payers that cover two-thirds of LN lives in the US.

Forecasting patient cost is not easy.
Aurinia announced a list price of $3,950 for 60 capsules. But that translates into only 10 days of therapy at the start up (also ongoing) dosing schedule. However, the label details complex dose reductions based on close physician monitoring and lab results especially in the first months. So, a patient that well tolerates the drug will require a maximum of 180 capsules a month….. that’s ~$12,000. A patient with complications may see dose reduction by up to two thirds, requiring only 2 tablets a day / 60 tablets a month….. that’s ~$4,000. Analysts suggest that once up and running the weighted average annual cost of therapy will likely top out at about $65,000.

Aurinia did not release distribution details. We expect that Lupkynis will launch into specialty pharmacy limited distribution given the cost of therapy, a black box warning, a complex dosing regimen, and testing for adverse reactions long term.

FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis

  • LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death –
  • LUPKYNIS demonstrated significantly improved renal response rates compared to typical standard-of-care (SoC) in clinical trials
  • LUPKYNIS is now commercially available in the U.S. – JANUARY 22, 2021 VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is now available to patients in the United States (U.S.).

In pivotal trials,………………………
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