Solution for injection in a pre-filled syringe or pre-filled pen for the treatment of axial spondyloarthritis in adults

About the medicinal product

The medicinal product Bimzelx contains the active substance bimekizumab.

Bimzelx was first authorised for the treatment of the skin disease plaque psoriasis in adults on 27 October 2022.

This indication extension means that Bimzelx can also be used to treat axial spondyloarthritis, including non-radiographic axial spondyloarthritis and ankylosing spondylitis (radiographic axial spondyloarthritis) in adults.

Axial spondyloarthritis is an inflammatory disease that mainly affects the spine and causes inflammation of the spinal joints. There are two forms: If no inflammation is visible on an X-ray, it is referred to as non-radiographic axial spondyloarthritis. However, if inflammation is visible on an X-ray, the disease is referred to as ankylosing spondylitis or radiographic axial spondyloarthritis.

Patients with axial spondyloarthritis are initially given other medicinal products. If these medicinal products are not sufficiently effective, they are given Bimzelx to reduce the signs and symptoms of the disease, reduce inflammation, and improve their physical functioning. Bimzelx can help to reduce back pain, stiffness, and fatigue, which can make everyday activities easier and improve quality of life.

In deciding whether to authorise the indication extension for Bimzelx, Swissmedic took into account the assessment of the European Medicines Agency (EMA) and the corresponding medicinal product information texts.

Since the assessment of the clinical data was based on the assessment reports of these foreign authorities, the preconditions for a full SwissPAR (Swiss Public Assessment Report – a detailed report for professionals) and a resulting Summary report on authorisation are not met. Swissmedic refers to the authorisation of the foreign reference authority (EMA Procedure Number EMEA/H/C/005316/II/0011, www.ema.europa.eu).

Further information on the medicinal product

Information for healthcare professionals:

Information for patients (package leaflet): 

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}