Xembify FDA approval : Spanish pharma company Grifols has been granted approval from the US Food and Drug Administration (FDA) for Xembify (immune globulin subcutaneous, human- klhw), the company’s 20% subcutaneous immunoglobulin solution, for the treatment of primary immunodeficiencies.
The FDA approval for Xembify to be subcutaneously injected for the treatment of primary humoral immunodeficiency (PI) in patients aged two years and more.
Grifols intends to launch Xembify in Q4 2019 in the US and is also seeking approval for the immunoglobulin in Canada, Europe and other regions.
Immunoglobulins are mainly used to treat primary and secondary immunodeficiencies, and also in rare neurological conditions like chronic inflammatory demyelinating polyneuropathy (CIDP).
Commenting on Xembify FDA approval, Joel Abelson – President of Commercial Bioscience Division at Grifols, 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.”
Apart from Xembify FDA approval, Grifols, which is focused on developing plasma-derived medicines, secured the regulator’s approval last year for GamaSTAN, its new intramuscular immunoglobulin. GamaSTAN has been designed to deliver immediate protection against hepatitis A and measles. The Spanish pharma company also has FDA approval for HyperRAB, a new anti-rabies immunoglobulin for the treatment of rabies virus exposed patients.
Grifol has allocated an investment of €1.4 billion between 2018 and 2022 to address the demands for plasma-derived medicines.
Currently, the Spanish pharma company is constructing a €140 million immunoglobulins purification and sterile filling facility in Clayton, North Carolina, which is scheduled to become operational by 2022.