FDA Approves New 10% IVIG Treatment for Adults with Primary Immunodeficiency

Source: Pharmacy Times

The U.S. Food and Drug Administration (FDA) has approved a new 10% intravenous immunoglobulin (IVIG) product called Qivigy for adults living with primary humoral immunodeficiency (PI): a group of immune disorders that make it difficult for the body to fight infections.

What is PI?

Primary immunodeficiency includes over 500 different immune disorders. People with PI often get frequent or severe infections because their bodies don’t produce enough antibodies. It’s estimated that up to 2% of Americans may be affected by some form of PI. While 2% of Americans may sound small, that translates to roughly 6.8 million people affected nationwide.

What the Study Showed:

Qivigy was tested in a year-long study called CARES10, which followed 47 adults with PI. Participants received IV infusions every 3 or 4 weeks for 12 months.

• No serious bacterial infections were reported during the entire study.
• Patients averaged only about two mild infections per year.
• No hospitalizations for infections occurred.
• Fewer than 5% of participants experienced mild side effects like headache, fatigue, or nausea.

Overall, patients had fewer interruptions in their daily lives and better protection against infection.

Why It Matters:

This approval adds a new option for doctors and patients managing PI, giving them another tool to prevent infections and improve quality of life. Pharmacists and infusion teams will play an important role in understanding how to safely administer and counsel patients on Qivigy.

At The Remedy Group, we stay informed about clinical advancements like these to better support our clients hiring in the specialty and infusion space and the candidates who bring this kind of life-changing care to patients every day.