Regulatory News - August 2019

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. A recent review concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia. 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 thus 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.

EMA has started a review of leuprorelin medicines after reports indicated that handling errors with the products during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the benefits of treatment. This review covers formulations called depot formulations, which are given by injection under the skin or into a muscle and release the active substance slowly over 1 to 6 months. These include implants as well as powders and solvents for the preparation of injections. Several of these formulations require complex steps to prepare the injection. Handling errors with these formulations have reportedly led to problems such as leakages from the syringe or failure to deliver implants from the applicator. EMA’s safety committee, PRAC, will now evaluate all available data and determine whether measures are needed to ensure that the medicines are prepared and administered appropriately. While the review is ongoing, healthcare professionals should carefully follow the handling instructions for leuprorelin medicines. Patients prescribed leuprorelin medicines who have any concerns should discuss them with their doctor.