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news.Plasma-derived medicines producer Grifols has secured approval from the US Food and Drug Administration (FDA) for its Xembify, a new 20% subcutaneous immunoglobulin solution, to treat primary immunodeficiencies.
Image: The US FDA’s Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration.
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According to the company, Xembify (immune globulin subcutaneous, human- klhw) is a 20% immune globulin solution for subcutaneous injection indicated to treat primary humoral immunodeficiency (PI) in patients two years of age and older.
Grifols commercial bioscience division president Joel Abelson said: “This approval reinforces Grifols’ longstanding commitment to patients and healthcare professionals by expanding our product portfolio to better serve individuals with primary immunodeficiencies.
“We are pleased to offer patients living with this challenging chronic disease another important treatment option.”
The company intends to introduce Xembify in the last quarter of this year in the US. It is also working with healthcare authorities to secure approval for Xembify in Canada, Europe and other markets.
Immunoglobulins are primarily used for the treatment of primary and secondary immunodeficiencies, in addition to rare neurological conditions such as chronic inflammatory demyelinating polyneuropathy (CIDP).
In 2018, the Plasma-derived medicines producer also received FDA approval for its new intramuscular immunoglobulin GamaSTAN, which offers immediate protection against hepatitis A and measles. It also received approval for new anti-rabies immunoglobulin HyperRAB to treat patients exposed to the rabies virus.
Grifols is planning to allocate €1.4bn (£1.2bn) as capital investments between 2018 and 2022 to meet the demand for plasma-derived medicines and reach its long-term growth plan.
The pharma company is currently involved in the construction of the world’s first purification and sterile filling facility of immunoglobulins in flexible packaging at its industrial complex in Clayton in the US state of North Carolina.
The purification and sterile filling plant, which is being developed with an investment of around €140m (£125m), is slated to be operational by 2022.
Based in Barcelona of Spain, Grifols is a healthcare company that operates four business divisions such as bioscience, diagnostic, hospital and bio supplies. With subsidiaries in 30 nations, the company provides its products and services in more than 100 countries.
