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Latest EPI-743 Stories

2014-03-19 23:25:02

EPI-743 gains key regulatory endorsement. Downingtown, PA, (PRWEB) March 19, 2014 Edison Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Status to EPI-743 for the treatment of Friedreich’s ataxia (http://www.prnewswire.com/news-releases/fda-awards-fast-track-status-to-edison-pharmaceuticals-epi-743-for-friedreichs-ataxia-250558901.html). This status will further accelerate the clinical development of EPI-743 now under way in two...

2014-03-17 00:23:45

EPI-743 in two phase 2 development studies for Friedreich's ataxia MOUNTAIN VIEW, Calif., March 17, 2014 /PRNewswire/ -- Edison Pharmaceuticals today announced that the United States Food and Drug Administration granted Fast Track designation to EPI-743, the company's lead drug, for the treatment of Friedreich's ataxia. EPI-743 is being developed for pediatric and adult mitochondrial disease, including Friedreich's ataxia. EPI-743 has successfully completed phase 1 and multiple...

2014-03-17 00:23:41

FDA approves IND for clinical trial in ultra rare orphan mitochondrial disease MOUNTAIN VIEW, Calif., March 17, 2014 /PRNewswire/ -- Edison Pharmaceuticals today announced the initiation of a phase 2 study entitled "A Phase 2 Safety and Efficacy Study of EPI-743 (Vincerinone(TM)) in Children with Pearson Syndrome." The Investigative New Drug application (IND) was approved by the Food and Drug Administration, Office of Hematology and Oncology Products. The trial is a...

2014-03-10 00:21:49

First subject enrolled in pivotal clinical trial MOUNTAIN VIEW, Calif., March 10, 2014 /PRNewswire/ -- Edison Pharmaceuticals today announced the initiation of a phase 2B/3 study entitled, "A Phase 2B/3 Open-label Study of EPI-743 in Children with Leigh Syndrome" to be conducted in conjunction with Dainippon Sumitomo Pharma Co, Ltd. The trial is an open-label study lasting six months. To be eligible for the trial, children must have clinical and radiographic evidence of Leigh...

2014-02-04 23:00:35

EPI-743 phase 2b Friedreich's ataxia trial fully enrolled. Downingtown, PA (PRWEB) February 04, 2014 Edison Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to vatiquinone (EPI-743) for the treatment of Friedreich’s ataxia (http://www.prnewswire.com/news-releases/fda-grants-edison-pharmaceuticals-epi-743-orphan-status-for-friedreichs-ataxia-243439351.html). Orphan status brings additional momentum and acceleration to the...

2014-02-04 00:21:05

EPI-743 in phase 2 development for Friedreich's ataxia MOUNTAIN VIEW, Calif., Feb. 4, 2014 /PRNewswire/ -- Edison Pharmaceuticals today announced that the US Food and Drug Administration has granted Orphan Status to vatiquinone for the treatment of Friedreich's ataxia. Vatiquinone is the International Nonproprietary Name (INN) for Edison's EPI-743. The INN is a unique international name issued by the World Health Organization. It is used to identify the active pharmacological...


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