European News

The EMA has initiated a series of actions to respond to the ongoing monkeypox outbreak, which was declared a Public Health Emergency of International Concern (PHEIC) by WHO on Saturday 23 July.

The EMA Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), established by the new regulation, will produce and maintain a formal list of critical medicines for the monkeypox public health emergency. This list will be drawn up in a collaborative process involving Member States, healthcare professionals, patients, and consumers.

An Emergency Task Force (ETF) has also been formally extended to deal with both COVID-19 and monkeypox. The ETF was initially set up during the pandemic to bring together expertise in the EU medicines regulatory network.

The EMA has recommended a conditional marketing authorisation in the EU for Tecvayli (teclistamab) for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies.

Multiple myeloma is a rare cancer of a type of white blood cells called plasma cells. Plasma cells are found in the bone marrow, and are an important part of the immune system, as they make the antibodies that enable the body to recognise and attack viruses or bacteria. In multiple myeloma, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. Instead of producing helpful antibodies, the cancer cells produce abnormal proteins which can cause complications.