Research & Development
AstraZeneca's Ultomiris approved in EU for gMG
23 September 2022 -

Pharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Friday that Ultomiris (ravulizumab) has been approved by European regulators as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness. Around 80% of people with gMG are AChR antibody positive meaning they produce specific antibodies (anti-AChR) that bind to signal receptors at the neuromuscular junction (NMJ), the connection point between nerve cells and the muscles they control. This binding activates the complement system, which is essential to the body's defence against infection, causing the immune system to attack the NMJ, leading to inflammation and a breakdown in communication between the brain and the muscles.

The approval by the European Commission marks the first and only approval for a long-acting C5 complement inhibitor for the treatment of gMG in Europe. It was based on positive results from a Phase III trial.

Ultomiris was approved in the US in April 2022 and Japan in August 2022 for certain adults with gMG. Additional regulatory reviews are ongoing in other countries.

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