logo
  

AstraZeneca : Ultomiris Recommended For Approval In EU For Children And Adolescents With PNH

Alexion's, a subsidiary of AstraZeneca (AZN.L,AZN), Ultomiris or ravulizumab has been recommended for marketing authorisation in the European Union for expanded use to include children and adolescents with paroxysmal nocturnal haemoglobinuria or PNH.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's positive opinion was based on results from Ultomiris Phase III trial, which demonstrated that Ultomiris was effective in achieving complete C5 complement inhibition through 26 weeks for the treatment of children and adolescents up to 18 years of age with PNH.

PNH is an ultra-rare and severe blood disorder characterised by the destruction of red blood cells that can cause a wide range of debilitating symptoms and complications, including thrombosis (blood clots), which can occur throughout the body, and result in organ damage and potentially premature death.

Ultomiris was first approved in the EU in 2019 for the treatment of adults with PNH and is also approved in the EU for the treatment of adults and children with atypical haemolytic uraemic syndrome (aHUS).

In June 2021, the US Food and Drug Administration approved the expanded use of Ultomiris to include children (one month of age and older) and adolescents with PNH, the first and only treatment for this age group in the US.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Apple has updated its Apple Maps with the release of iOS 15 to now provide new ways to explore major cities through a new 3D view. Maps users on the new iOS in London, Los Angeles, New York City, and the San Francisco Bay Area can experience a three-dimensional city view of these major cities. Deutsche Lufthansa AG has launched additional flights to the United States on short notice, aiming to tap the surging demand following the planned end of U.S. travel restrictions. The German flag carrier is also increasing domestic flights to its European hubs amid high demand. Starting in October, the company is increasing German domestic flights by 45 percent, compared with July. Gas utility Southern California Gas Co. or SoCalGas and its parent company Sempra Energy announced agreements to resolve substantially all material civil litigation related to the 2015 Aliso Canyon natural gas storage facility leak. SoCalGas, which operates the storage facility, will record an after-tax charge of approximately $1.1 billion this month.
Follow RTT