The European Medicines Agency (EMA) is recommending that bacterial lysate medicines authorised for respiratory conditions should only be used for prophylaxis of recurrent respiratory tract infections, with the exception of pneumonia.
It follows a new review of evidence by the EMA’s human medicines committee (CHMP). After considering findings from clinical studies, data on side effects reported with these medicines and advice from an expert group on infectious diseases, the committee concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, and said they should not be used for these purposes.
The review found some evidence of effectiveness of these medicines in the prevention of recurrent respiratory tract infections and the Committee recommended that use of the medicines for prevention can continue; however, the companies must provide further data on safety and effectiveness from new clinical studies by 2026.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. The prescribing information of the medicines will be updated with the new indication and a warning against use for prevention of pneumonia.