Grifols announced this Monday that its subsidiary Biotest has received approval from the FDA (Food and Drug Administration) from the United States for Yimmugo, an “innovative” intravenous immunoglobulin (Ig) for the treatment of primary immunodeficiencies. The group thus obtains approval for a key treatment in the North American market, at a time when it seeks to focus on industrial growth to try to regain confidence after the stock market crisis unleashed at the beginning of the year by accusations of whitewashing. by the bearish firm Gotham City Research.
The authorization of the Yimmugo is one of the main innovation milestones established by Grifols for the whole of 2024.
In a statement, the pharmaceutical company explained that Yimmugo, developed by Biotest, joins its “solid” franchise of intravenous and subcutaneous Ig treatments, at a time of growing demand for plasma-derived medications to treat immunodeficiencies, which occur when a part of the body’s immune system is absent or does not function properly, and other diseases.
Yimmugo, the first drug in Biotest’s portfolio approved in the US, is produced through a highly advanced process in the plant Next Level from Biotest in Dreieich (Germany), recently certified by the FDA, which already has approval for production and marketing in Europe.
“The launch of Yimmugo in the US in the second half of 2024 follows the successful launch in Europe in late 2022 and will contribute to Grifols’ future revenue growth and profitability,” the company states.
Grifols explains that Yimmugo is the first of the three plasma proteins in Biotest’s portfolio that will be marketed in different countries, including the United States. The other two, both in an advanced stage of development, are a fibrinogen concentrate for acquired fibrinogen deficiency – it would be the first approved for this indication in the US, and trimodulin, a polyvalent Ig to treat community-acquired pneumonia or Severe community-acquired pneumonia.
“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,” said Roland Wandeler, president of the business unit. Grifols Biopharma.
“The strategic acquisition of Biotest and the integration of its specialized resources have significantly accelerated Grifols’ innovation, strengthening its product portfolio and boosting its leadership in the sector,” the company states.
Grifols shares rose slightly at mid-morning, although, in the early stages of the session, they rose almost 3%.
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