17 April 2012

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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