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Dicerna receives recommendation from EMA committee to designate DCR-PHXC for the treatment of primary hyperoxaluria in the EU

Published 07/11/2018, 10:23 AM
© Reuters.  Dicerna receives recommendation from EMA committee to designate DCR-PHXC for the treatment of primary hyperoxaluria in the EU
DRNA
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  • Dicerna Pharmaceuticals (NASDAQ:DRNA) +1.36% announced that the European Medicines Agency’s Committee for Orphan Medicinal Products has recommended designating DCR-PHXC, the Company’s lead GalXC product candidate, as an orphan medicinal product for the treatment of primary hyperoxaluria in the European Union.
  • The European Commission is expected to review the COMP opinion and issue a final ruling within 30 days of receipt.
  • The company also announced that the FDA granted Orphan Drug Designation to DCR-PHXC for the treatment of PH.
  • The Company initiated the PHYOX Phase 1 clinical trial of DCR-PHXC in normal healthy volunteers in the fourth quarter of 2017 and dosed the first patient with PH in May 2018, with clinical proof-of-concept data anticipated in the second half of 2018.
  • Press Release
  • Now read: Melinta Therapeutics: Could The H.R. 6294 Bill Improve The Prospects Of Antibiotic Innovators?


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