EMA has instructed that, from now onwards the bacterial lysate medicines should only be used against recurrent respiratory infections, with pneumonia as the only exception. This step was taken after reviewing that there is no robust data that can prove these medicines are effective in treating existing respiratory infection or prevention of pneumonia.
EMA’s human medicines committee (CHMP) used the clinical studies data, adverse event data related to these medicines and advice from the expert group.
The data was found to be limited but the review showed the effectiveness of these medicines in prevention of recurrent respiratory infections. Safety profile was also compliant. CHMP allowed the further use of these medicines but told the companies to provide more data on safety and effectiveness from new clinical studies by 2026.
Broken down bacterial cells are used to prepare Bacterial Lysate medicines. These medicines stimulate the immune system to recognize and fight infections. These medicines are available in the form of oral dosage form, as inhalation liquid through nasal cavity and in the form of intramuscular and subcutaneous injection.
Mr Vinod Arora, Principal Advisor, IGMPI
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