CHMP positive for extended approval to measles pre-/post exposure prophylaxis – CSL Behring

On 23 April 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Privigen. The marketing authorisation holder for this medicinal product is CSL Behring GmbH.

The CHMP adopted a new indication as follows:

Replacement therapy in adults, children, and adolescents (0-18 years) in:

• Primary immunodeficiency syndromes (PID) with impaired antibody production (see section 4.4).
• Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.

* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.

Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (0-18 years) in whom active immunisation is contraindicated or not advised.

Consideration should also be given to official recommendations on intravenous human immunoglobulin use in measles pre-/post exposure prophylaxis and active immunisation.

Immunomodulation in adults, children, and adolescents (0-18 years) in:

• Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
• Guillain-Barré syndrome.
• Kawasaki disease (in conjunction with acetylsalicylic acid; see section 4.2.).
• Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
• Multifocal motor neuropathy (MMN).