Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Novartis Announces Agreement With FDA On Label Changes For Gilenya - Quick Facts

RELATED NEWS
Trade NVS now with 

Novartis (NVS: Quote) said it agreed with the US Food and Drug Administration on label changes for Gilenya, or fingolimod.

The update to the Gilenya prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment and more specific recommendations for treatment initiation for patients with relapsing forms of MS in the United States. The company noted that the update marks the conclusion of discussions initiated in December 2011.

The updated FDA label for Gilenya indicates that all patients initiating treatment with Gilenya should have an electrocardiogram prior to the first dose of the medicine and after the six-hour first-dose observation period in addition to hourly measurement of blood pressure and heart rate. Additionally, specific initiation guidance for patients is now provided to better aid healthcare providers. Further, there are revised recommendations on how to re-initiate therapy should Gilenya be interrupted.

If therapy is interrupted for patients who are already taking Gilenya, they should undergo the new recommended monitoring upon treatment re-initiation as per the revised recommendations on the duration of interruption depending on duration of prior treatment.

Register
To receive FREE breaking news email alerts for Novartis AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that its third quarter loss widened slightly from last year, as higher costs and expenses more than offset a 45% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue. After ending the previous session modestly lower, stocks moved mostly higher over the course of the trading day on Thursday. The gains on the day more than offset yesterday's losses, lifting the major averages to their best closing levels in a month. Sen. Lindsey Graham, R-S.C., is seen as a long shot for the Republican presidential nomination in 2016, and his chances may have gotten worse after he was recorded joking about the prospects for "white men" if he were elected president.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.