FDA approves Grifols company Xembify for treatment of primary immunodeficiency disease in patients 2 years of age and older
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, Grifolscompany(http://announced that Xembify (subcutaneous immunoglobulin, 20%) has been approved by the U.SFoodDrug(http://Regulatory Authority (
FDA(http://) for the treatment of primary immunodeficiency disease (PIPs) in patients 2 years of age and olderprimary immunodeficiency disease (PI) includes, but is not limited to, congenital protoglobulinemia, common variant immunodeficiency (CIVD), X chain of c-propien globulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID)about xembifyXembify, which is also Grifols' first 20% subcutaneous immunoglobulin, is scheduled to reach the U.Smarket in the fourth quarter of 2019 and is working with other regulators to obtain regulatory approval signed by Canada, Europe and other marketsXembify's launch will provide an important treatment option for patients with primary immunodeficiency andhealth professionals with medical (http:// while strengthening Grifols' long-term commitment to better serve patients by expanding the portfolio of product (http:// Xembify's approval reflects Grifols' strong commitment to its R-D-i projects and innovation, which allows the company to continue to develop new formulations and indications to enhance its product portfolio Recent highlights of the project include FDA approval in 2018 of a new intramuscular immunoglobulin product, GamaSTAN, and a new anti-rabies immunoglobulin HyperRAB, which provides immediate protection against hepatitis A and measles, and the latter for treating patients infected with rabies virus
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