Catalent secures softgels commercial supply agreement with Aurinia

The CDMO will manufacture recently FDA-approved Lupkynis as a softgel dosage form at its St Petersburg, Florida, facility

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.

The CDMO'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.

The FDA approved Lupkynis in Jauary 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.

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 US, making people with LN a significant subset of the total SLE population.