Catalent has signed a multi-year commercial supply agreement with Aurinia Pharmaceuticals for LUPKYNIS (voclosporin), a drug to treat adult patients with lupus nephritis (LN).
 
LUPKYNIS was approved by the U.S. 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.
 
Catalent will manufacture LUPKYNIS as a softgel dosage form at its pharmaceutical softgel center of excellence in St. Petersburg, FL.
 
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.
 
Catalent’s 435,000 sq.-ft. 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.

“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.”