Cuvitru Approval History
- FDA approved: Yes (First approved September 13th, 2016)
- Brand name: Cuvitru
- Generic name: immune globulin subcutaneous (human)
- Dosage form: Injection
- Company: Shire US, Inc.
- Treatment for: Primary Immunodeficiency Syndrome
Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment of primary humoral immunodeficiency (PI).
FDA approval follows publication of the results of a Phase II/III study of Cuvitru in 74 patients with primary immunodeficiency. Cuvitru was determined safe and effective with a tolerability profile enabling infusions to be administered at higher rates and volumes compared to conventional SC preparations.
Cuvitru is a ready-to-use injection administered via subcutaneous infusion at regular intervals from daily up to every two weeks. Common side effects include infusion site reactions, headache, nausea, fatigue, diarrhea, and vomiting.
Development History and FDA Approval Process for Cuvitru
|Sep 14, 2016||Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency|
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