USA – Grifols’ Biotest, a leading producer of plasma-derived medicines, has received approval from the United States Food and Drug Administration (FDA) for its innovative immunoglobulin therapy, Yimmugo, to treat primary immunodeficiencies (PID).
This approval marks a significant milestone in the company’s efforts to expand its portfolio of intravenous and subcutaneous immunoglobulins and meet the growing demand for plasma-derived medicines.
Yimmugo, developed by Biotest, is an intravenous immunoglobulin (Ig) therapeutic designed as a substitution therapy for primary antibody deficiency syndromes.
The therapy uses a polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg).
It is manufactured at Biotest’s new FDA-certified “Next Level” production facility in Dreieich, Germany, which is already approved for European production and marketing.
The FDA approval of Yimmugo is a significant step forward for Grifols, as it adds to the company’s strong franchise of industry-leading intravenous and subcutaneous Ig treatments.
This approval also paves the way for other Biotest proteins in late-stage development, including fibrinogen and trimodulin, poised to enter the market in the coming years.
“We aim to increase the availability of and access to immunoglobulin therapies worldwide, thereby improving patient care,” said Peter Janssen, CEO of Biotest, in a recent press release.
“With this approval, we are committed to providing innovative treatment options for patients with primary immunodeficiencies who rely on these essential medicines in their daily lives.” he further stated.
The strategic acquisition of Biotest and the integrating of its specialized resources have significantly accelerated Grifols’ innovation, deepened its product pipeline, and furthered its industry leadership.
The company’s commitment to developing innovative immunodeficiency treatments is reflected in its strong portfolio of immunoglobulins and ongoing efforts to expand its offerings.
Yimmugo is the first of a trio of Biotest plasma proteins on the horizon destined for markets including the U.S.
The other two, both in late-stage development, are a fibrinogen concentrate (FC) to treat acquired fibrinogen deficiency and trimodulin, a polyvalent Ig to treat community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP).
The FDA approval of Yimmugo is a testament to Grifols’ dedication to improving patient care through innovative treatments.
As the company continues to expand its portfolio of immunoglobulins, it is poised to impact the treatment of immunodeficiencies and other medical conditions significantly.
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