Grifols Announces FDA Approval Of Subcutaneous Immunoglobulin Xembify

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Grifols (GRFS) announced that Xembify, its new 20% subcutaneous immunoglobulin, has been approved by the 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, Grifols added. The company intends to allocate EUR 1,400M toward capital investments over the 2018-2022 period "in order to meet the growing demand for plasma-derived medicines and reinforce its long-term growth plan".

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