The EU may see a new option for measles prevention in vulnerable patients following a regulatory recommendation to expand the use of a human immunoglobulin therapy.

In its April 2026 meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended an extension of the marketing authorization for Privigen (human normal immunoglobulin, CSL Behring GmbH). The proposed update adds a new indication for measles pre- and postexposure prophylaxis in susceptible adults, children, and adolescents (0-18 years) in whom active immunization is contraindicated or not advised. 

This new use would complement Privigen’s established indications in both replacement therapy and immunomodulation across a range of immune-related conditions.

The expanded indication is supported by clinical and observational evidence demonstrating that immunoglobulin therapy can prevent measles following exposure, particularly in high-risk populations. A systematic review of postexposure prophylaxis found that immunoglobulin is effective in reducing the risk of confirmed measles, although the available data are limited and heterogeneous. The CHMP’s summary did not identify a specific supporting trial. 

Mechanism and Current Applications 

Privigen contains human normal immunoglobulin, a highly purified immunoglobulin G (IgG) fraction derived from pooled human plasma. It exerts a dual mechanism of action by replacing deficient IgG to restore physiologic humoral immunity and, at higher doses, by immunomodulating dysregulated immune responses through Fc receptor blockade, complement modulation, and neutralization of pathogenic autoantibodies.

The therapy is currently approved for these purposes:

Replacement therapy in:

• Primary immunodeficiency syndromes with impaired antibody production
• Secondary immunodeficiencies in patients with severe or recurrent infections, inadequate response to antimicrobial therapy, and either proven specific antibody failure or reduced serum IgG levels

Immunomodulatory treatment in:

• Primary immune thrombocytopenia in patients at high bleeding risk or prior to surgery
• Guillain-Barré syndrome
• Kawasaki disease, in conjunction with acetylsalicylic acid
• Chronic inflammatory demyelinating polyneuropathy
• Multifocal motor neuropathy

Implementation Timeline 

Detailed prescribing recommendations for the broadened therapeutic use will be outlined in an updated Summary of Product Characteristics, which will be published on the EMA website in all official European Union languages. This publication will occur following the European Commission’s decision on the marketing authorization changes, which typically occurs within 67 days of the committee’s positive opinion adoption.