The US Food and Drug Administration (FDA) has granted approval for Shire’s Cuvitru treatment in adult and paediatric patients aged two years and older.

Cuvitru is used to treat 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 does not function properly.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Cuvitru is the only 20% subcutaneous immunoglobulin (IG) option without proline and has the ability to infuse up to 60ml a site and 60ml an hour.

"Shire’s broad IG treatment portfolio offers a wide range of options to help physicians tailor treatment regimens.”

It is generally associated with a low incidence of local adverse and systemic reactions in the North American clinical study.

Medical City Children Hospital pediatric allergy and immunology medical director Richard Wasserman said: “In the clinical study, primary immunodeficiency patients tolerated Cuvitru favourably, despite the use of higher infusion site volumes and more rapid infusion rates than have been routine in the past.

See Also:

“The availability of Cuvitru as a high-concentration, subcutaneous IG provides primary immunodeficiency patients with the dosing flexibility that allows them to customise their therapy to best fit their individual needs."

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Approved in 17 European countries in June, Cuvitru is expected to be launched in the US soon.

The company also expects to initiate additional global regulatory submissions for the drug this year and next year.

Shire US commercial head Perry Sternberg said: “As Cuvitru is now approved in the US following European approval earlier this year, Shire’s broad IG treatment portfolio offers a wide range of options to help physicians tailor treatment regimens to meet the priorities of their patients managing these life-long disorders.”