Solution for injection in a pre-filled syringe for adjuvant treatment to standard therapy of generalised myasthenia gravis (gMG) in anti-acetylcholine receptor(AChR) antibody-positive adults

About the medicinal product

Zilbrysq contains the active substance zilucoplan.

Zilbrysq is used in addition to the standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

Myasthenia gravis is a rare, chronic, neuromuscular autoimmune disease that leads to muscle weakness. In this disease, the immune system attacks the body's own acetylcholine receptors or associated proteins. The resulting disruption to the transmission of signals between nerves and muscles leads to severe muscle weakness, reduced mobility, shortness of breath, extreme fatigue, swallowing disorders and significant impairment of day-to-day activities.

Zilbrysq blocks a specific protein in the immune system (C5 complement protein). By blocking this protein, zilucoplan prevents the body's own immune system from attacking the connections between nerves and muscles, thus alleviating the disease symptoms.

Since myasthenia gravis is a rare, life-threatening disease, the medicinal product Zilbrysq has been authorised as an orphan drug. The term “orphan drug” is used to refer to important medicines for rare diseases.

In deciding whether to authorise the medicinal product Zilbrysq, Swissmedic took into account the assessments of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), 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 authorisations by the foreign reference authorities.

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.}