Novartis Updates Drug Labels

Story first appeared on Reuters.
Novartis International AG / Novartis updates US label on GilenyaR following discussions with the FDA . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

• Updated Gilenya label provides further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients in the United States.
• Prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment.
• Update to label marks the conclusion of discussions initiated in December 2011.

Basel, April 20, 2012 - Novartis announced today agreement with the US Food and Drug Administration (FDA) on label changes for GilenyaR (fingolimod). These changes are an attempt to alleviate any unrest about their drug related to recent reports of death, according to Washington DC Personal Injury Lawyers.

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 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 (ECG) 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.

As of February 2012, approximately 36,000 patients have been treated with Gilenya in clinical trials and in the post-marketing setting.

Gilenya represents an important treatment option for relapsing forms of MS. Choosing appropriate patients for Gilenya therapy and patient safety is essential.


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Novartis Pill Responsible for Fatalities in Patients

Story first appeared in the Wall Street Journal

Novartis AG Friday said a patient treated with its multiple-sclerosis pill Gilenya has been diagnosed with a rare and often fatal brain disease.

The Swiss drug maker said the patient, whose identity hasn't been disclosed, had been previously treated with another MS drug, Tysabri, co-marketed by Biogen Idec Inc. and Elan Corp. PLC, which has been already associated with progressive multifocal leukoencephalopathy, or PML.

The current assessment is that Tysabri is the drug most likely associated with this case of PML. However, a contribution of Gilenya to the evolution of this case can't be excluded.

The development comes at a critical time for Novartis's Gilenya, whose safety profile has recently come into question after the death of one person in the U.S. last autumn within 24 hours of starting treatment. Heart problems in some patients were also reported.

The European Medicines Agency, the body responsible for licensing Gilenya in Europe a year ago, is expected to issue a decision on the safety of the medicine on April 20 following an in-depth review.  Washington D.C. Products Liability Lawyers are following the case.

Novartis said it doesn't know of any confirmed PML cases in patients treated with Gilenya, also known as fingolimod, who hadn't previously been treated with Tysabri. The company said details on the case are being submitted to health authorities.

The development has to be taken seriously, but the question is more whether this is a trend, with a second or even third case coming up in the next few weeks. The timing is unfortunate, with the pill's risk-profile under investigation and certainly, there was no need for a second problem.

Gilenya, which is currently the only oral multiple-sclerosis treatment on the market, has so far been approved in more than 55 countries, with more than 25,000 patients having been prescribed it.

Industry analysts have said it could generate sales of at least $1 billion a year, helping to offset lost revenue caused by the expiry of Novartis' top-selling heart drug Diovan.

Europe's drug regulator in January launched an in-depth review of the drug's benefits and risks, and recommended that doctors closely monitor the hearts of patients after they have been given the first dose of the drug. The final product liability verdict is likely to have a big impact on the product's prospects and investor sentiment to Novartis shares.

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