FDA approval for innovative immunoglobulin Yimmugo for the treatment of patients with primary immunodeficiencies
Biotest AG announced that its intravenous immunoglobulin Yimmugo has been approved in the United States for the treatment of patients with primary immunodeficiencies (PID)
At the same time, the site in Dreieich, Germany, has been certified by the FDA. Previously, Biotest had already received approval for production and marketing in European markets.
"With this approval, we aim to increase the availability of and access to immunoglobulin therapies worldwide, thereby improving patient care," said Peter Janssen, CEO of Biotest AG. "We are very pleased that with Yimmugo we can bring a product from Germany to the American market for the first time in the history of Biotest.”
Yimmugo is the first drug approved in the U.S. to be manufactured using an innovative process in the new "Biotest Next Level" production facility. It was analyzed for safety, efficacy and tolerability in extensive pivotal studies. The U.S. approval was preceded by an approval process with the FDA in which Yimmugo and its manufacturing facility were successfully demonstrated to meet the FDA's approval requirements within the first cycle and without delay.
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