The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AstraZeneca Plc's (NASDAQ: 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.
Price Action: AZN shares are up 1.64% at $66.32 during the premarket session on the last check Monday.
See more from Benzinga
Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.