Catalent Announces Commercial Supply Agreement with Aurinia Pharmaceuticals for Newly-Approved LUPKYNIS™ Softgels
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it recently signed a multi-year commercial supply agreement with Aurinia Pharmaceuticals, a biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need, for LUPKYNIS™ (voclosporin), a drug to treat adult patients with lupus nephritis (LN).
LUPKYNIS was approved by the U.S. Food and Drug Administration (FDA) in January 2021 for use in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN, and is the first FDA-approved oral therapy for LN.
Under the terms of the agreement, Catalent will manufacture LUPKYNIS as a softgel dosage form at its pharmaceutical softgel center of excellence in St. Petersburg, Florida.
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). Approximately 40% of patients with SLE develop LN at some point in their lifetime, and approximately a third have LN when they are diagnosed with SLE. There are approximately 200,000 – 300,000 people with SLE in the United States, making people with LN a significant subset of the total SLE population.
“Catalent has a long track record in bringing novel drugs to market, and has supported over 80% of all prescription pharmaceutical softgel brand launches in the U.S. It has nearly 90 years of experience in the formulation and manufacturing of softgels for both pharmaceutical and consumer health products, which it has drawn upon to jointly develop LUPKYNIS with Aurinia,” commented Dr. Aris Gennadios, President, Softgel and Oral Technologies, Catalent. “We know the benefits that the dosage form offers developers and patients, and look forward to working with Aurinia on the commercial production of this innovative therapeutic option for patients with lupus nephritis going forward, having previously partnered on its development.”
Catalent’s 435,000 square-foot site in St. Petersburg is the company’s primary softgel development and manufacturing facility in North America and has a capacity of 18 billion capsules per year.
Additional information on LUPKYNIS, including the important safety information for the product, can be found at https://ir.auriniapharma.com/press-releases/detail/210/fda-approves-aurinia-pharmaceuticals-lupkynis.