Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

FDA Approves Subcutaneous Gammagard

By Drug Discovery Trends Editor | July 25, 2011

Baxter International Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous administration of GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency (PI). The approval of this new route of administration will allow physicians and PI patients to work together to determine which route of administration of GAMMAGARD LIQUID is most appropriate. Subcutaneous use of GAMMAGARD LIQUID allows patients to self-administer their therapy at home on a weekly basis.

“The FDA approval of a subcutaneous route of administration for GAMMAGARD LIQUID offers PI patients the option to administer GAMMAGARD LIQUID either intravenously or subcutaneously, depending on their individual needs,” said Richard Schiff, M.D., Ph.D., medical director for Baxter’s gammaglobulin trials. “Building upon years of strong clinical data of GAMMAGARD LIQUID, our subcutaneous clinical trial in patients with PI demonstrated efficacy consistent with that seen in other clinical studies of intravenous and subcutaneous immune globulin.” (The most frequently reported adverse reactions were local site reactions, which occurred in 2.7% of infusions.)

Baxter supports advocacy organizations and treatment centers through programs focusing on patient care and continued access to therapy such as GARDian, a program providing educational resources, insurance support and guidance for therapy continuity. The GARDian program is also creating new features to support patients who choose GAMMAGARD LIQUID for subcutaneous use.

GAMMAGARD LIQUID is indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age or older. It offers flexibility to clinicians who treat patients with PI, as it is now available via two routes of administration, in a total of five dosing sizes, and contains no added sugars, sodium, or preservatives. It is processed using a dedicated three-step viral inactivation/removal process.

Date: July 25, 2011
Source: Baxter International Inc. 


Filed Under: Drug Discovery

 

Related Articles Read More >

Roche in Drug Discovery & Development Pharma 50
Roche’s bispecific antibody Lunsumio wins priority review from FDA for non-Hodgkin lymphoma
Tiffany Hurd
CB Therapeutics biz dev lead sees upside for psychedelics in mental health and beyond
Pharmacovigilance
A new era of pharmacovigilance: Worldwide master key for drug safety monitoring
Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50