Cytheris announces US Orphan Drug Designation for CYT107 for Progressive Multifocal Leucoencephalopathy
Cytheris SA announced that the US Food and Drug Administration (FDA) has granted an Orphan Drug Designation for Cytheris’ CYT017, glycosylated recombinant human interleukin-7 (glycosylated r-h-IL7), for the treatment of progressive multifocal leukoencephalopathy (PML). This designation from the FDA follows orphan drug designation for the same indication granted in Europe in July 2012 from the European Commission.
“This second orphan drug designation strongly adds support from the FDA to that of the European Commission for the development of CYT107 as the treatment for PML. The disease has a mortality rate of around 40 to 50 per cent at one year whilst survivors often present severe neurological complications and disabilities,” said Therese Croughs, chief medical officer at Cytheris. “We have already gathered clinical data supporting the efficacy and safety of CYT107 in PML through several compassionate use treatments. We are committed to conduct a pivotal clinical study rapidly to obtain regulatory approval and make CYT107 available as soon as possible to all patients suffering from this devastating disease.”
Cytheris has previously obtained scientific advice from the European Medicines Agency (EMA) for a pivotal phase IIb study protocol with CYT107 in HIV-related PML. Cytheris has reached an agreement with the EMA on the key study endpoints and will start this study in early 2013.
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