EMA is recommending that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia. This follows a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not be used for these purposes.
In the review, EMA’s human medicines committee (CHMP) considered the results of clinical studies, data on side effects reported with these medicines, and advice from an expert group on infectious diseases.
Although data are limited, the review found some evidence of effectiveness of these medicines in the prevention of recurrent respiratory tract infections and the safety profile is in line with what is expected for this type of product. The CHMP therefore recommended that use of the medicines for prevention can continue, but the companies must provide further data on safety and effectiveness from new clinical studies by 2026.