FDA Approves Immunoglobulin Therapeutic to Treat Primary Immunodeficiencies

Global healthcare company, Grifols, announced on June 17, 2024 that its subsidiary Biotest has garnered its first FDA approval with the intravenous immunoglobulin (Ig) therapeutic, Yimmugo, which Grifols hopes to launch commercially in the United States in the second half of 2024 (1). FDA notified Biotest of the approval in a letter dated June 13, 2024 (2).

According to a press release from Grifols, Yimmugo was introduced in Europe at the end of 2022 and is being produced at a new, FDA-certified facility in Dreieich, Germany. This location was also previously approved for production and marketing throughout Europe.

Grifols cites a “growing demand for plasma-derived medicines” such as Yimmugo to treat primary immunodeficiencies (PIDs), meaning when a portion of the body’s immune system is missing or not functioning properly.

The Immune Deficiency Foundation further defines PIDs as a group of conditions, in excess of 450, which are considered rare, chronic, and disruptive to the immune system. They are also known as inborn errors of immunity (3).

Roland Wandeler, president of the Grifols Biopharma Business Unit, emphasized in the company’s press release the need for continued development of therapeutics for PIDs.

“The addition of Biotest’s Yimmugo to our strong portfolio of intravenous and subcutaneous immunoglobulins provides another innovative treatment option for patients with primary immunodeficiencies who rely on these essential medicines in their daily lives,” Wandeler said.

Two other plasma proteins being developed under the Biotest nameplate are currently in late-stage development for future clearance in the US and other worldwide markets. One is a fibrinogen concentrate (FC) for treatment of acquired fibrinogen deficiency; this would be the first FC approved for this indication in the US, according to Grifols (1). The other, trimodulin, is a polyvalent Ig to combat community-acquired and severe community-acquired pneumonia.

Grifols acquired Biotest in 2022 and called it “a strategic transaction that will contribute to expanding and diversifying Grifols’ plasma supply; strengthening its operations and revenues in Europe, Middle East and Africa; and supporting the company’s economic performance” (4). The acquisition increased the company’s available plasma-derived therapies and its fractionation capacity to more than 20 million liters of plasma annually.

“The Biotest acquisition is a fundamental milestone in our transformation plan, and is fully aligned with our growth strategy—strengthening our global plasma capacity, expanding our product portfolio in order to benefit more patients, complementing our innovation efforts with high value-added projects, and accelerating our presence in new markets,” said Víctor Grífols Deu, co-CEO of Grifols, at the time of the acquisition (4).

References

1. Grifols. Grifols’ Biotest Receives FDA Approval for Innovative Yimmugo® Immunoglobulin to Treat Primary Immunodeficiencies. Press Release. June 17, 2024. grifols.com/en/view-news/-/news/grifols-biotest-receives-fda-approval-for-innovative-yimmugo-immunoglubulin-to-treat-primary-immunodeficiencies
2. FDA. Yimmugo. FDA.gov. 2024. fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yimmugo (accessed June 18, 2024).
3. Immune Deficiency Foundation. What is PI? primaryimmune.org. primaryimmune.org/understanding-primary-immunodeficiency/what-is-pi (accessed June 18, 2024).
4. Grifols. Grifols Completes the Acquisition of Biotest: A Strategic and Transformational Transaction to Accelerate Growth and Innovation. Press Release. April 25, 2022. grifols.com/en/view-news/-/news/grifols-completes-the-acquisition-of-biotest-a-strategic-and-transformational-transaction-to-accelerate-growth-and-innovation