Shire's Cuvitru gains FDA approval for primary immunodeficiency

14 September 2016
2019_biotech_test_vial_discovery_big

The US Food and Drug Administration has granted approval for Ireland-headquartered Shire’s (LSE: SHP) 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 immunoglobulin (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 60mL (12 grams) per site and 60mL 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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology