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FDA approves Alexion’s Ultomiris for generalised myasthenia gravis

gMG is a rare autoimmune neuromuscular disease that causes a loss of muscle function and severe weakness

Alexion

Alexion Pharmaceuticals, a subsidiary of AstraZeneca, has received approval from the US Food and Drug Administration (FDA) for its long-acting C5 complement inhibitor, Ultomiris (ravulizumab-cwvz).

The drug is recommended for use for adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive, which accounts for 80% of people living with the condition.

gMG is a chronic, rare autoimmune neuromuscular disease that causes severe weakness and a loss of muscle function. In the US, the diagnosed prevalence of gMG is estimated at around 90,000.

The FDA based its approval on positive data taken from the CHAMPION-MG phase 3 trial, a global, randomised study that assessed the safety and effectiveness of Ultomiris in adults with gMG.

The trial showed that Ultomiris was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at Week 26. MG-ADL is a patient-reported scale that evaluates patients’ abilities to do daily activities.

The decision from the FDA signals the first and only approval of a long-acting C5 complement inhibitor for gMG.

NEJM Evidence recently published results online from the CHAMPION-MG trial and presented the data at the 2022 American Academy of Neurology Annual Meeting in April.

Samantha Masterson, CEO, Myasthenia Gravis Foundation of America (MGFA), said: “gMG takes a physical and emotional toll on those living with the disease. We are grateful for continued innovation and research into new treatment and dosing options to meet the needs of more patients and reduce the treatment burden.

“With the approval of Ultomiris, we’re excited that MG patients now have another option to consider as part of their personalised treatment strategies that may offer more convenience and improve muscle weakness.”

Marc Dunoyer, CEO, Alexion, commented: “Ultomiris, the only long-acting C5 inhibitor, will benefit a broader range of patients, including those with milder symptoms. As presented at the 2022 American Academy of Neurology Annual Meeting, Ultomiris has demonstrated clinical benefit through 60 weeks, with treatment every eight weeks, compared to Soliris every two weeks.”

Multiple regulatory authorities are reviewing submissions for Ultomiris for the treatment of gMG, including those in the European Union (EU) and Japan.

Article by
Fleur Jeffries

28th April 2022

From: Regulatory

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