Our Take
This is regulatory approval for an existing therapy to address a real outbreak, not a new medical advance—CSL's immunoglobulin has been in use for 18 years, but Europe is only now clearing it for measles post-exposure prophylaxis.
Why it matters
Measles cases in Europe remained roughly twice 2023 levels through early 2025 (per the European Centre for Disease Prevention and Control reporting cited in the source). Clinicians treating immunocompromised patients, pregnant women, and infants now have a documented fallback when vaccination is contraindicated.
Do this week
Infectious disease and immunology leads: review your facility's exposure prophylaxis protocols against Privigen's approved indications (immunocompromised patients, non-immune pregnant women, vulnerable infants) and confirm supply agreements before measles clusters hit your region.
CSL wins European approval for measles post-exposure prophylaxis
The European Commission authorised Privigen, a human immunoglobulin therapy, for pre- and post-exposure measles prophylaxis. The indication covers susceptible high-risk individuals, including immunocompromised patients, pregnant women without evidence of immunity, and infants for whom active vaccination is unsuitable.
Privigen is a ready-to-use 10% liquid intravenous immunoglobulin stabilised with proline. The company notes it carries a well-established safety profile based on clinical use and long-term real-world experience. The US approved the therapy in 2007; it is now available in more than 60 countries. In Europe, Privigen is also authorised for immunoglobulin replacement in primary and secondary immunodeficiencies and for immunomodulatory use in rare neurological and inflammatory conditions.
Emmanuelle Lecomte Brisset, CSL's Head of Global Regulatory Affairs and Safety, stated that the approval ensures clinicians have access to an immunoglobulin option where passive protection may be considered. The European approval rests on clinical and real-world evidence demonstrating safety and efficacy in preventing measles and protecting high-risk patients.
Outbreaks have driven demand for non-vaccination pathways
The approval arrives amid a measles resurgence in Europe. The European Centre for Disease Prevention and Control reported a marked spike in 2024, with cases remaining elevated through early 2025 at roughly twice the 2023 baseline. Immunocompromised patients, pregnant women, and young infants cannot receive live attenuated measles vaccine, leaving them reliant on vaccination status of close contacts or post-exposure intervention.
Immunoglobulin therapy works by delivering concentrated antibodies that neutralise the measles virus after exposure, offering rapid passive protection. For clinicians managing exposed high-risk patients outside the vaccination window, this represents a documented pathway to reduce infection risk.
Audit your post-exposure protocols for eligible patients
Facilities treating immunocompromised patients, obstetric departments managing non-immune pregnant women, and neonatal units caring for vulnerable infants should map Privigen's approved indications against current exposure prophylaxis guidelines. The therapy is no longer investigational in Europe; it is a licensed option with 18 years of real-world use data. Confirm supply arrangements and staff familiarity with intravenous immunoglobulin administration before a cluster occurs in your catchment area.