FDA approves Cuvitru [Immune Globulin Subcutaneous (Human), 20% Solution]to treat primary immunodeficiency.- Shire plc

Shire plc announced that the FDA has granted approval for Cuvitru [Immune Globulin Subcutaneous (Human), 20% Solution]? in adult and pediatric patients two years of age and older. Cuvitru is a treatment for patients with primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body�s immune system is missing or functions improperly; it affects up to six million people worldwide. With the approval of Cuvitru, Shire now has the broadest portfolio of intravenous and subcutaneous immunolglobulin (IG) products, including the only once-a-month subcutaneous treatment option. 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. Regardless of infusion rate or volume per site, Cuvitru was generally associated with a low incidence of local adverse and systemic reactions (0.022/infusion and 0.042/infusion, respectively) in the North American clinical study.

Comment: Cuvitru was filed at EMA in June 2016.