Biotech Values

[DewDiligence]

It seems that the pall cast over Gilenya by the need to monitor for cardiac conduction problems with the initial dose is being accepted by patients and providers. But, one or two more cases of PML in Gilenya users would be a different story. To the extent that Tysabri users cross over to Gilenya, PML is a potentially bigger risk than conduction problems…

Since the FDA and EMA labels do not specify a washout period for Tysabri->Gilenya switches, neurologists will have to figure this out on their own. Waiting a minimum of six months would seem to be prudent insofar as this was a requirement in the phase-3 Gilenya trials.

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