FDA approves Shire’s immunodeficiency drug

The Food and Drug Administration recently approved Shire’s new drug Cuvitru to treat patients with primary immunodeficiency diseases.

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Primary immunodeficiency diseases represent a group of more than 300 rare chronic disorders where part of the body’s immune system is missing or does not function properly.

Cuvitru, injected once a month, can infuse up to 60 milliliters per site per hour, which results in fewer injection sites and shorter treatment durations for patients.

“In the clinical study, primary immunodeficiency patients tolerated Cuvitru favorably despite the use of higher infusion site volumes and more rapid infusion rates than have been routine in the past,” said Richard Wasserman, MD, PhD, medical director of pediatric allergy and immunology at Dallas-based Medical City Children’s Hospital.

Dublin-based Shire will launch Cuvitru in the U.S. in the next few weeks.

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