Europe's CHMP Recommends Approving AstraZeneca's Asthma, Neuromuscular Disorder Treatments

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AstraZeneca Plc's AZN Ultomiris (ravulizumab) for generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Ultomiris would be the first and only approved long-acting C5 complement inhibitor for AChR antibody-positive gMG in the EU if authorized.
The positive opinion is based on results from the CHAMPION-MG Phase 3 trial, in which Ultomiris was superior to placebo on a patient-reported scale that assesses patients' abilities to perform daily activities.
Ultomiris was approved in the U.S. in April for adults with gMG who are AChR antibody-positive, and regulatory reviews are ongoing in additional countries, including Japan.
The CHMP has also backed AstraZeneca's Tezspire (tezepelumab) as add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high-dose inhaled corticosteroids and other maintenance treatment.
Tezspire was approved as an add-on maintenance treatment of severe asthma in the U.S. in December 2021.
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