Shire plc (SHPG - Free Report) announced the launch of Cuvitru in the U.S. Cuvitru, an immune globulin subcutaneous 20% solution, gained FDA approval for primary humoral immunodeficiency in adult and pediatric patients aged two years and older in Sep 2016.
According to the press release issued by Shire, primary immunodeficiencies comprise a group of more than 300 genetic disorders in which a portion of the body's immune system is missing or does not function properly. The disease is estimated to affect as many as six million children and adults across the world.
We note that commercial availability of Cuvitru has expanded Shire’s immunoglobulin product portfolio with intravenous, conventional and subcutaneous treatment options.
We remind investors that Cuvitru became part of Shire’s portfolio following its Jun 2016 merger with Baxalta.
In Europe, Cuvitru has gained a regulatory approval earlier this year. Shire expects to initiate additional regulatory submissions for the drug in other countries in late 2016 and 2017.
Shire currently carries a Zacks Rank #3 (Hold).
SHIRE PLC-ADR Price
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