Grifols, A Spanish producer of plasma-derived medicines, has secured US approval for Xembify, its new 20% subcutaneous immunoglobulin used to treat primary immunodominances.
The approval marks the culmination of an important research and development initiative for Grifols, as well as an opportunity to enhance the Bioscience Division’s product portfolio.
“This approval reinforces Grifols’ longstanding commitment to patients and healthcare professionals by expanding our product portfolio to better serve individuals with primary immunodeficiencies,” said to Joel Abelson, President of Commercial Bioscience Division at Grifols.
The company plans to launch Xembify in the US in the Q4 2019 and is working with healthcare authorities to obtain approval in Canada, Europe and other markets.
Immunoglobulins are mainly used to treat primary and secondary immunodeficiencies, as well as rare neurological conditions, such as chronic inflammatory demyelinating polyneuropathy.