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Grifols Wins Early FDA OK For SCIg Xembify, Setting Stage For Margin Growth

 
• By Sten Stovall

Analysts said Grifols is poised for profit margin growth after the US FDA approved its first 20% subcutaneous immunoglobulin, Xembify, for treating primary immunodeficiencies.

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Self-Injectable Immunoglobulins treat primary and secondary immunodeficiencies • Source: Shutterstock

Grifols SA said on 4 July that the US Food and Drug Administration approved Xembify, its first 20% self-injectable immunoglobulin to treat primary immunodeficiencies, and that the Spain-based group aims to launch the product in the US during the fourth quarter while working to get additional approvals in Canada, Europe and other global markets.

The FDA OK came earlier than had been expected, reflecting Ximbify's high tolerability, which bodes well for a more competitiveness and

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