Mithra receives Orphan Drug Designation from FDA for E4 in neonatal encephalopathy treatment

  • The US Food and Drug Administration granted E4 an ODD for the treatment of life-threatening hypoxic ischemic encephalopathy (HIE)
  • This new designation expands E4’s broad potential in therapeutic areas beyond the leading indications in women’s health
  • Mithra continues its preclinical studies in HIE, a severe pediatric syndrome that affects 30,000 newborns each year in Europe and the United States

Liege, Belgium, 2 April 2019 – 7 :30  CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has received Orphan Drug Designation (ODD) from the Food and Drug Administration (FDA) for the use of E4 in Neonatal Encephalopathy (NE). In addition to its three late-stage E4-based product candidates for contraception, perimenopause and menopause, Mithra is developing E4’s potential in other therapeutic areas, particularly in neuroprotection for the treatment of hypoxic ischemic encephalopathy (HIE), a life-threatening form of neonatal asphyxia.