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