Gilenya patient develops PML

Published date: 05 Aug 2013 at 2:50PM

A patient who had been taking the MS treatment, Gilenya, has developed a rare brain condition known as progressive multifocal leukoencephalopathy (PML), the drug’s manufacturer Novartis has confirmed.

The patient had been taking Gilenya for seven months, but it is not yet known whether the development of PML is in any way related to the drug.

Atypical features

Novartis said in a statement that, given several atypical features of the case, it was “working with the reporting physician to further understand all possible contributing factors, including those beyond treatment”.

Approximately 71,000 patients worldwide have been treated with Gilenya, and to date there have been no cases of PML attributed to the drug.

Well tolerated

In two previous cases of PML, the patients had previously taken Tysabri, which is known to increase the risk of PML.

Gilenya is an oral MS treatment licensed in the UK for the treatment of rapidly evolving relapsing remitting MS and is generally well tolerated, though some people may experience side effects

Read more about Gilenya

Update 09/09/2013: Novartis have completed investigations and due to atypical features of the case, they have concluded that this case of PML is unlikely to be attributable to Gilenya. The US Food and Drug Administration (FDA) are now looking into this case. We will report their findings as they come.

Page last updated: 09 Sep 2013

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