“The FDA’s timely approval of our Orphan Drug Designation for INFRADURE to treat hepatitis D is a key milestone in our broader hepatitis program as data gathered through clinical trials for INFRADURE in hepatitis D may serve as relevant support for other clinical uses of INFRADURE including hepatitis C and hepatitis B,” stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. “Following on the FDA’s recent clearance to proceed with our Phase IIb study of the EPODURE™ Biopump technology to treat anemia, and the positive comments of the National Institutes of Health Recombinant DNA Advisory Committee, we see this Orphan Drug Designation from the FDA as another important step in the regulatory pathway for our Biopump platform. As Dr. Haffner has indicated, we are hopeful that this will lead to a streamlined regulatory pathway to approval of INFRADURE in hepatitis D and believe that it could also help advance the regulatory pathway for other applications of our Biopump technology in the U.S.”“We look forward to updating our clinical trial plans in view of the Orphan Drug Designation. We anticipate that hepatitis D clinical studies will use INFRADURE Biopumps that are fundamentally identical to those which will be used for the treatment of hepatitis C in our two Phase I/II studies in Israel which are now awaiting final approval from the Israeli Ministry of Health.” added Pearlman.
Medgenics Receives Orphan Drug Designation From FDA For INFRADURE Biopump To Treat Hepatitis D
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