Posted by Michael Wonder on 04 Jul 2019
Grifols announces FDA approval of Xembify, 20% subcutaneous immunoglobulin for primary immunodeficiencies
4 July 2019 - Xembify is Grifols’ first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies.
Grifols announced today that Xembify, its new 20% subcutaneous immunoglobulin, has been approved by the U.S. FDA. Xembify is used to treat primary immunodeficiencies.
The company plans to launch Xembify in the United States in the last quarter of 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 (CIDP). Immunoglobulin use continues to grow in major markets. From 2015-2017, immunoglobulin volumes have experience annual growth rates of about 10% for primary and secondary immunodeficiencies and CIDP.
