EU Panel Curtails Use of Bacterial Lysate Meds for Respiratory Conditions

Megan Brooks

Disclosures

June 28, 2019

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that use of bacterial lysate medicines, which are authorized for the treatment of respiratory conditions, be restricted to the prevention of recurrent respiratory infections, with the exception of pneumonia.

Bacterial lysate medicines should not be prescribed for the treatment of existing respiratory infections or for prophylaxis of pneumonia, owing to lack of efficacy data, the CHMP said.

The recommendation follows a review of bacterial lysate medicines by the committee that was launched last June at the request of Italy.

At the time, the EMA said, "Recent studies have cast doubt on the effectiveness of bacterial lysate medicines in reducing the number and severity of respiratory infections in adults and children who experience repeated infections. In addition, in very rare cases, these medicines are known to cause serious side effects related to the immune system."

The CHMP review found "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," the EMA said in a news release.

Although data are limited, the review found some evidence of effectiveness of bacterial lysate medicines for preventing recurrent respiratory tract infections. In addition, the safety profile of these drugs was in line with what is expected for this type of product, the EMA said.

In their review, the committee considered results of safety and efficacy data from clinical trials and advice from infectious disease experts.

The prescribing information of bacterial lysate medicines will be updated with the new indication and with a warning against use for prevention of pneumonia, the EMA said.

Use of bacterial lysate medicines for the prevention of recurrent respiratory infections "can continue, but the companies must provide further data on safety and effectiveness from new clinical studies by 2026," the EMA said.

In Europe, bacterial lysate medicines are sold under several brand names, including Broncho Munal, Broncho Vaxom, Buccalin, Immubron, Immucytal, Ismigen, Lantigen B, Luivac, Ommunal, Paspat, Pir-05, Polyvaccinum, Provax, Respivax, and Ribomunyl.

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