logo
Share SHARE
FONT-SIZE Plus   Neg

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

Novartis (NVS) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
The U.S. Food and Drug Administration Thursday announced it will start regulating all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, just like it regulates cigarettes. Under the new rules, e-cigarettes manufacturers should receive marketing authorization from the... News Corp. (NWS, NWSA) on Thursday posted a loss for the third quarter, hurt largely by lower advertising revenue at news and information segment and a stronger dollar, partly offset by growth in the digital real estate business. The New York-based media company reported a third-quarter loss of $149... Action-sports camera maker GoPro Inc. (GPRO), Thursday posted a loss for the first quarter, as revenues nearly halved and margins dropped sharply reflecting weak demand for its wearable cameras. Loss for the quarter were higher than what Wall Street analysts estimated, but revenues trumped expectations. San...
comments powered by Disqus
Follow RTT