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
French car maker Renault SA reported Friday higher profit in its fiscal 2015, with strong growth in automotive profit and revenues. The company announced higher dividend. Looking ahead, for fiscal 2016, Renault expects to increase group revenues at constant exchange rates and improve group operating margin. Shares of Rolls-Royce Holdings Plc were gaining around 13 percent in the morning trading in London after the engine maker reported more-than doubled profit in its fiscal year 2015, with lower one-time items. Underlying earnings were hurt by weakness in Marine markets. Further, the company halved its dividends, and still expects lower revenues next year. German steel giant ThyssenKrupp AG reported a loss in its first quarter, compared to last year's profit as sales and orders were hurt by sharp deterioration in materials businesses. The company said its overall performance in the first quarter was within its full-year forecast corridor. Looking ahead, the company continues to expect higher net income and flat sales for fiscal 2016.
comments powered by Disqus
RELATED NEWS
Trade NVS now with 
Follow RTT