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Here’s Why the Approval of Lupkynis Has Biotech Investors Buzzing

Here’s Why the Approval of Lupkynis Has Biotech Investors Buzzing

The US FDA approved Lupkynis as the first oral drug for lupus nephritis.

The US Food and Drug Administration (FDA) has approved the first oral drug for lupus nephritis called Lupkynis (voclosporin). This drug — developed by Vancouver, Canada-based Aurinia Pharmaceuticals — is used to treat a kidney disease that is caused by lupus which can lead to kidney failure, heart complications and even death.

The medicine is given alongside an immunosuppressant to treat adults with active lupus nephritis. According to a survey done on more than 200 US rheumatologists and nephrologists in 2020, there is a high unmet need for treating lupus nephritis.

Lupkynis is an improvement on cyclosporine, which is an old immunosuppressive drug used to reduce the risk of post-transplant organ rejection and is an active ingredient in Restasis, a popular dry eye treatment.

Lupkynis sees a sizeable market opportunity as the second drug approved by the FDA for lupus nephritis. Many in the industry have been talking about Aurinia Pharmaceuticals’ rising stock. The shares (NASDAQ: AUPH) recently jumped by 26 percent on the 25th of January. Analysts who are following this stock have raised their sale estimates for Lupkynis after Aurinia received their approval. This is because several respondents describe the drug as a potential best-in-class calcineurin inhibitor which is a mechanism that may help accelerate adoption.

According to BioPharmaDive, Aurinia Pharmaceuticals has a setlist price of $3,950 for 60 capsules as part of a wallet. Each wallet would last around 10 days based on the approved dosing protocol, and the company expects their average net revenue to be around $65,000 per patient per year.

“The Lupkynis approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – all of whom we thank for their partnership in the development of this innovative novel treatment. We are thrilled to bring Lupkynis to the people impacted by this devastating condition,” said Peter Greenleaf, president and CEO of Aurinia Pharmaceuticals, in a statement. “The approved label supports the efficacy and safety of Lupkynis as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of Lupkynis.”

In 2020, GSK’s Benlysta received approval as the first medicine for adult patients with active nephritis in the US. According to a press release about the approval, “Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form of lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant.”

“Approximately 40 percent of patients with systemic lupus erythematosus develop lupus nephritis, which causes inflammation in the kidneys and can lead to end-stage kidney disease.  Benlysta is the first medicine approved to treat systemic lupus and adults with active lupus nephritis, an important treatment advance for patients with this incurable autoimmune disease,” said Dr. Hal Barron the chief scientific officer and president of R&D at GSK.

NCBI states that Chloroquine is a drug used to prevent malaria and amebiasis. Hydroxychloroquine is a less toxic metabolite of chloroquine that is used to treat diseases such as lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis and Sjogren’s syndrome.

Furthermore, in 2020, it was believed that hydroxychloroquine and chloroquine would help in treating patients with COVID-19. This was quickly directed by the FDA as not being an approved treatment for the illness. The evidence suggested that it is not effective in treating or preventing COVID-19 and that the potential benefits of the drug do not outweigh the known and potential risks. Moreover, the FDA had reported that there were shortages of the drug and people with lupus were having trouble receiving their prescriptions but had later resolved this when the COVID-19-related hype around the drugs died down.

“The Lupus Foundation of America estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus,” said a press release about the recent Lupkynis and Benlysta approvals. “As many as half of the patients with systemic lupus will develop nephritis. With new tools to fight this devastating disease, specialists may finally be able to bring hope to patients.”