Aurinia’s LUPKYNIS® Receives Key Approval in Japan for LN
Aurinia Pharmaceuticals Celebrates Approval of LUPKYNIS in Japan
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) is excited to announce that voclosporin, marketed as LUPKYNIS, has been officially approved by the Japanese Ministry of Health, Labour, and Welfare for treating lupus nephritis (LN). This significant development marks an important step forward in improving treatment accessibility for lupus patients in Japan.
Collaboration with Otsuka Pharmaceutical
The approval stems from a collaborative effort with Otsuka Pharmaceutical Co., Ltd., which submitted the new drug application (NDA) in November 2023. The decision was informed by comprehensive data from the AURORA Clinical Program, featuring a pivotal 12-month Phase 3 study and a subsequent two-year extension study. These studies closely assessed the effectiveness and safety of LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids versus MMF and low-dose glucocorticoids alone.
Addressing a Critical Need for Lupus Nephritis
Upon hearing the news of the approval, Peter Greenleaf, President and Chief Executive Officer of Aurinia, expressed enthusiasm about the opportunity this brings to patients. "We are thrilled to achieve this milestone that will provide access to LUPKYNIS in Japan, where there is a high rate of lupus nephritis among Japanese lupus patients. Our successful strategic partnership has allowed us to bring LUPKYNIS to LN patients in various regions, including Europe and now Japan. This addresses a significant unmet need for patients suffering from this challenging condition," he stated.
Benefits of the Collaboration Agreement
Aurinia’s partnership with Otsuka includes a comprehensive licensing agreement established in December 2020. Through this agreement, Aurinia is set to receive $10 million in payments upon approval in Japan, in addition to low double-digit royalties on net sales post-launch. The strategic collaboration enables Aurinia to supply the necessary product to Otsuka, promoting an efficient launch strategy.
LUPKYNIS: Pioneering Treatment for Lupus Nephritis
It is well-known that lupus nephritis is a severe form of systemic lupus erythematosus (SLE), impacting thousands of lives. Lupus nephritis significantly affects individuals, particularly women and people of color, with around 120,000 diagnosed in the U.S. alone. Uncontrolled lupus nephritis can lead to irreversible kidney damage, making timely and effective treatment critical.
Importance of Routine Screening and Early Treatment
Medical guidelines strongly advocate for routine screenings for LN in all SLE patients during medical visits. However, research indicates that a significant portion of SLE patients, around 50%, do not receive necessary screenings for LN. With Aurinia’s commitment to enhancing health outcomes for these individuals, the focus remains on educating both patients and healthcare providers about the need for regular screening and access to transformative therapies.
The Unique Mechanism of LUPKYNIS
LUPKYNIS is recognized as a second-generation calcineurin inhibitor that operates through a dual mechanism: it acts as an immunosuppressant by inhibiting T-cell activation and cytokine production, while also promoting the stability of podocytes within the kidney. Clinical trials have demonstrated that LUPKYNIS in conjunction with standard care can preserve kidney health without relying on high-dose glucocorticoids, an important consideration in managing lupus nephritis.
Aurinia’s Commitment to Autoimmune Disease Treatment
Aurinia Pharmaceuticals is dedicated to developing innovative therapies targeting autoimmune conditions with significant unmet clinical needs. Besides LUPKYNIS, the company is working on AUR200, a promising therapy aimed to target both BAFF and APRIL, which could set a new standard of care in treating autoimmune diseases.
Frequently Asked Questions
What is lupus nephritis?
Lupus nephritis is a serious kidney condition caused by systemic lupus erythematosus, which can lead to kidney damage if not treated properly.
Who is eligible to receive LUPKYNIS?
LUPKYNIS is indicated for adult patients diagnosed with active lupus nephritis in combination with a background immunosuppressive therapy regimen.
Why is LUPKYNIS significant for lupus nephritis patients?
LUPKYNIS offers a new treatment option with a beneficial mechanism that may improve kidney health and reduce reliance on high-dose glucocorticoids.
What potential side effects are associated with LUPKYNIS?
Common side effects may include hypertension, renal impairment, and infections, requiring regular monitoring during treatment.
How does Aurinia plan to educate healthcare providers about LUPKYNIS?
Aurinia is committed to educating healthcare providers on the importance of routine screenings for LN and the benefits of LUPKYNIS to improve patient outcomes.
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