CSL has received European Commission marketing authorisation for Privigen, its human immunoglobulin therapy indicated for pre‑ and post‑exposure prophylaxis to prevent and reduce the risk of measles in situations where vaccination is contraindicated or not recommended.
The decision follows a marked resurgence of measles across Europe. Health authorities, including the European Centre for Disease Prevention and Control, reported a sharp rise in cases in 2024. In 2025, infections remained elevated at roughly twice the levels seen in 2023.
Emmanuelle Lecomte Brisset, Head of Global Regulatory Affairs and Safety at CSL, said: ‘While vaccination remains the most effective way to prevent measles, outbreaks across Europe highlight the urgent need for additional tools to protect those at risk.’ She added that the approval ‘ensures clinicians have access to an immunoglobulin option where passive protection may be considered.’
Privigen is a ready‑to‑use human immunoglobulin prepared from screened donor plasma. It is indicated for susceptible high‑risk individuals, including immunocompromised patients, pregnant women without evidence of immunity and infants or other vulnerable contacts for whom active immunisation is unsuitable.
CSL notes that the therapy is supported by a well‑established safety profile based on clinical use and long term real world experience.
Immunoglobulin therapy provides concentrated antibodies capable of neutralising the measles virus after exposure and may offer passive antibody protection. This makes it a potential option for people who cannot rely on vaccination or who require rapid prophylactic support following exposure.
The European approval is based on clinical and real‑world evidence demonstrating the safety and efficacy of Privigen in preventing measles and protecting high‑risk patients.
Privigen, the first and only 10% ready‑to‑use human liquid intravenous immunoglobulin stabilised with proline, was first approved in the US in 2007.
In Europe it is also authorised as an immunoglobulin replacement therapy for primary and secondary immunodeficiencies and for immunomodulatory use in several rare neurological and inflammatory conditions. It is available in more than 60 countries worldwide.
