AZN

FDA Oks AstraZeneca's Ultomiris For Treatment Of Adult Patients With Generalised Myasthenia Gravis

(RTTNews) - The U.S. Food and Drug Administration approved AstraZeneca plc.'s (AZN, AZN.L) Ultomiris or ravulizumab-cwvz for the treatment of adult patients with generalised myasthenia gravis or gMG who are anti-acetylcholine receptor antibody-positive.

The approval was based on positive results from the CHAMPION-MG Phase III trial, in which 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, a patient-reported scale that assesses patients' abilities to perform daily activities.

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks.

The regulatory submissions for Ultomiris for the treatment of gMG are currently under review with multiple health authorities, including in the European Union and Japan.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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