Date: 2012-05-23
Type of information:
Product name: Recombinant human interleukin-7 (CYT107)
Compound: Recombinant human interleukin-7 (CYT107)
Therapeutic area:
Action mechanism: Recombinant human interleukin-7 (CYT107) is a critical immune-modulator for immune T-cell recovery and enhancement. As a growth factor and cytokine physiologically produced by marrow or thymic stromal cells and other epithelia, IL-7 has a critical and, at some steps, a non-redundant stimulating effect on T lymphocyte development, notably on thymopoïesis and, downstream from the thymus, on homeostatic expansion of peripheral T-cells.
Company: Cytheris (France)
Disease: progressive multifocal leukoencephalopathy
Latest news: * On May 11, 2012, the Committee for Orphan Medicinal Products (COMP) of the EMA has adopted a positive opinion recommending recombinant human interleukin-7 for designation as an orphan medicinal product for the treatment of progressive multifocal leukoencephalopathy.
* On July 10, 2012 , Cytheris SA, a clinical-stage biopharmaceutical company focused on treating lymphopenia driven diseases, has announced that the European Commission has granted an orphan designation for Cytheris’ CYT017, glycosylated recombinant human interleukin-7 (glycosylated r-h-IL7), for the treatment of Progressive Multifocal Leukoencephalopathy (PML).
* On October 24, 2012, Cytheris has announced that the 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.
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.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2012-10-24
Orphan status UE: 2012-07-06
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
