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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

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Swiss drug giant Novartis AG reported Tuesday higher profit in its third quarter with improved sales in all divisions. Both core earnings and top line beat market estimates. For fiscal 2017, the company continues to expects net sales to be broadly in line with prior year and core operating income to be broadly in line or decline low single digit, both at constant currency rates. World's largest oil company Saudi Aramco's initial public offering is on track and the listing will be in the second half of 2018, CEO Amin Nasser said in an exclusive interview with CNBC. There have been reports that the much awaited IPO might be delayed by one year. Taco Bell, the Mexican fast food chain of Yum! Brands Inc., is reportedly testing a new dessert product called the "Kit Kat Chocoladilla" at select locations in Wisconsin. It was tested last year in the UK.
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