COPENHAGEN (Reuters) - Denmark’s Novo Nordisk said on Tuesday its hemophilia product Novoseven had proved effective in the treatment of intracerebral hemorrhage (ICH) in a phase II study.
“Based on the data, Novo Nordisk will immediately liaise with regulatory agencies in the effort to achieve approval for the use of Novoseven as the first pharmaceutical treatment of ICH,” the company said in a statement.
Novoseven is currently registered for treatment of bleeding episodes in hemophilia patients.
Novo Nordisk said studies indicated that every year around 250,000 people in North America, Europe and Japan have an ICH, or hemorrhagic stroke.
The study involved 400 patients in 20 countries, Novo Nordisk said. The company said the results demonstrated that patients treated with Novoseven had a significantly improved neurological and functional outcome compared to the placebo group.
“This is the first time such encouraging results have been observed in any ICH trial,” it said.
Copyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
