Approval follows the positive opinion granted by European Committee for Medicinal Products for Human Use (CHMP) in July 2022
LUPKYNIS is the first oral medicine approved in both the U.S. and Europe for the treatment of adults living with active lupus nephritis
Approval triggers $30.0 million milestone payment, to be recognized as revenue in the 3rd quarter
VICTORIA, Canada I September 19, 2022 I Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the European Commission (EC) has granted marketing authorization of LUPKYNIS® (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The U.S. Food and Drug Administration (FDA) approved LUPKYNIS on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.
The centralized marketing authorization is valid in all European Union (EU) member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.
“Today marks the first approved oral treatment for lupus nephritis in both the European Union and provides adults across Europe living with this potentially life-threatening disease a new treatment option,” said Peter Greenleaf, President and Chief Executive Officer, Aurinia. “People with lupus nephritis and their physicians have long been challenged by the lack of treatments available. In partnership with Otsuka, we’re excited to reach patients across Europe with a meaningful therapy that can help enable positive long-term kidney outcomes.”
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of the agreement, Aurinia will receive a $30.0 million EC approval-related milestone payment to be recognized as revenue in the quarter, with receipt of cash to follow within 30 days of invoicing. In addition to the milestone payment, Aurinia is eligible to receive further payments tied to additional regulatory and reimbursement milestones, low double-digit royalties on future net sales, as well as revenues for the supply of product to Otsuka under a cost-plus arrangement.
A decision on marketing authorization for LUPKYNIS in Great Britain is expected from the UK Medicines and Healthcare products Regulatory Agency in the coming weeks. In addition, a marketing authorization application (MAA) for LUPKYNIS was submitted to the Swiss Agency for Therapeutic Products (Swissmedic) and is currently under review. Swissmedic previously granted orphan drug status to voclosporin in LN in February 2022.
The EC approval of LUPKYNIS is based on the results of the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study, which demonstrated 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.
About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.
About LUPKYNIS
LUPKYNIS® is the first U.S. FDA-approved and EC-approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. 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. Boxed Warning, warnings, and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis. The Company’s head office is in Victoria, British Columbia, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.
SOURCE: Aurinia Pharmaceuticals
Post Views: 366
Approval follows the positive opinion granted by European Committee for Medicinal Products for Human Use (CHMP) in July 2022
LUPKYNIS is the first oral medicine approved in both the U.S. and Europe for the treatment of adults living with active lupus nephritis
Approval triggers $30.0 million milestone payment, to be recognized as revenue in the 3rd quarter
VICTORIA, Canada I September 19, 2022 I Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the European Commission (EC) has granted marketing authorization of LUPKYNIS® (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The U.S. Food and Drug Administration (FDA) approved LUPKYNIS on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.
The centralized marketing authorization is valid in all European Union (EU) member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.
“Today marks the first approved oral treatment for lupus nephritis in both the European Union and provides adults across Europe living with this potentially life-threatening disease a new treatment option,” said Peter Greenleaf, President and Chief Executive Officer, Aurinia. “People with lupus nephritis and their physicians have long been challenged by the lack of treatments available. In partnership with Otsuka, we’re excited to reach patients across Europe with a meaningful therapy that can help enable positive long-term kidney outcomes.”
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of the agreement, Aurinia will receive a $30.0 million EC approval-related milestone payment to be recognized as revenue in the quarter, with receipt of cash to follow within 30 days of invoicing. In addition to the milestone payment, Aurinia is eligible to receive further payments tied to additional regulatory and reimbursement milestones, low double-digit royalties on future net sales, as well as revenues for the supply of product to Otsuka under a cost-plus arrangement.
A decision on marketing authorization for LUPKYNIS in Great Britain is expected from the UK Medicines and Healthcare products Regulatory Agency in the coming weeks. In addition, a marketing authorization application (MAA) for LUPKYNIS was submitted to the Swiss Agency for Therapeutic Products (Swissmedic) and is currently under review. Swissmedic previously granted orphan drug status to voclosporin in LN in February 2022.
The EC approval of LUPKYNIS is based on the results of the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study, which demonstrated 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.
About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.
About LUPKYNIS
LUPKYNIS® is the first U.S. FDA-approved and EC-approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. 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. Boxed Warning, warnings, and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis. The Company’s head office is in Victoria, British Columbia, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.
SOURCE: Aurinia Pharmaceuticals
Post Views: 366
