RDR: FDA Approves Cuvitru for Primary Immunodeficiency Disorders

September 20, 2016

By Andrew Black at Rare Disease Report

The FDA has approved Shire’s Cuvitru  [Immune Globulin Subcutaneous (Human), 20% Solution] for patients with primary immunodeficiency. The approval follows the recent publication of a Phase II/III study of Cuvitru among North American patients in the Journal of Clinical Immunology.

Patients with primary immunodeficiency disease typically require life-long intravenous (IV) or subcutaneous (SC) immunoglobulin (Ig) replacement therapy to prevent recurrent infections.

In the clinical study, patients with primary immunodeficiency tolerated Cuvitru favorably despite the use of higher infusion site volumes and more rapid infusion rates than have been routine in the past.

About Cuvitru

Cuvitru is an Immune Globulin (IG) Subcutaneous (Human), 20% Solution for the treatment of primary immunodeficiency in adult and pediatric patients two years of age and older.

Cuvitru is the only 20% subcutaneous IG treatment option without proline and with the ability to infuse up to 60 mL (12 grams) per site and 60 mL per hour, per site as tolerated, resulting in fewer infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments.

About Primary Immunodeficiency

Primary immunedeficiencies (PI) are a group of more than 300 disorders (many of which are rare) in which part of the body’s immune system is missing or does not function properly. hen any part of a person’s immune system is absent or dysfunctional, the individuals are susceptible to infections, and it may take longer to recover from infections.

Some rare primary immunodeficiencies include: Wiskott-Aldrich Syndrome, DiGeorge Syndrome, Hyper IgE Syndrome, Ataxia-Telangiectasia and many more.

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