- Today's Hot Chat Topics
- Member Benefits
- Manage your personalised Watchlist.
- Set up an online Virtual Portfolio.
- Participate in Share Chat.
- See more trades and director dealings.
- Play the Fantasy Share Trading Game.
Share:
HomeShare PricesShare ChatFinance NewsSharecast NewsRegulatory NewsBlogsLive PricesShares BookshopFinance ToolsMembers
Latest Share Chat
Finance & Stock Market News
UPDATE 1-EU agency reviews heart safety of Novartis MS drug
Fri, 20th Jan 2012 10:42
LONDON, Jan 20 (Reuters) - The European Medicines Agency said on Friday it had begun a review
The move came after reports of heart problems in patients and the death of one person in the United States within 24 hours of starting treatment.
The Swiss drugmaker said last month it was investigating whether Gilenya, seen by analysts as a potential multibillion-dollar seller, caused the death of the 59-year-old U.S. patient.
Gilenya can temporarily slow the heart rate. Although this usually returns to normal after a few hours, the European watchdog said it was advising doctors to intensify cardiovascular monitoring after the first dose.
The U.S. Food and Drug Administration said on Dec. 20 it was also looking into the U.S. case. Regulators on both sides of the Atlantic said the exact cause of the patient's death was still unexplained.
European authorities approved Gilenya last March for people with highly active relapsing-remitting multiple sclerosis (RRMS), the commonest form of the debilitating disease.
More than 30,000 people have received the drug worldwide.
(Reporting by Ben Hirschler; Editing by Kate Kelland and Dan Lalor) Keywords: NOVARTIS/GILENYA
(ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net)(www.twitter.com/re tersBenHir)
COPYRIGHT
Copyright Thomson Reuters 2012. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
of the benefits and risks of Novartis's multiple sclerosis drug Gilenya, due to concern over the effects of the medicine on the heart after the first dose.
The move came after reports of heart problems in patients and the death of one person in the United States within 24 hours of starting treatment.
The Swiss drugmaker said last month it was investigating whether Gilenya, seen by analysts as a potential multibillion-dollar seller, caused the death of the 59-year-old U.S. patient.
Gilenya can temporarily slow the heart rate. Although this usually returns to normal after a few hours, the European watchdog said it was advising doctors to intensify cardiovascular monitoring after the first dose.
The U.S. Food and Drug Administration said on Dec. 20 it was also looking into the U.S. case. Regulators on both sides of the Atlantic said the exact cause of the patient's death was still unexplained.
European authorities approved Gilenya last March for people with highly active relapsing-remitting multiple sclerosis (RRMS), the commonest form of the debilitating disease.
More than 30,000 people have received the drug worldwide.
(Reporting by Ben Hirschler; Editing by Kate Kelland and Dan Lalor) Keywords: NOVARTIS/GILENYA
(ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net)(www.twitter.com/re tersBenHir)
COPYRIGHT
Copyright Thomson Reuters 2012. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
